69482 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

1The Commission voted 3–2 to publish this final 

rule, with changes, in the Federal Register. 

Chairman Inez M. Tenenbaum, Commissioners 

Robert S. Adler and Thomas H. Moore voted to 

publish the final rule with changes. Commissioners 

Nancy A. Nord and Anne M. Northup voted against 

publication of the final rule. Chairman Tenenbaum, 

Commissioner Adler, and Commissioner Moore 

issued a joint statement. Commissioner Nord and 

Commissioner Northrup issued statements. The 

statements can be found at http://www.cpsc.gov/pr/ 

statements.html. 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1107 

[CPSC Docket No. CPSC–2010–0038] 

Testing and Labeling Pertaining to 

Product Certification 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC,’’ ‘‘Commission,’’ 

or ‘‘we’’) is issuing a final rule that 

establishes protocols and standards with 

respect to certification and continued 

testing for children’s products. The final 

rule also establishes requirements for 

labeling of consumer products to show 

that the product complies with the 

certification requirements under section 

14(a) of the Consumer Product Safety 

Act (‘‘CPSA’’). The final rule 

implements section 14(a)(2) and (i) of 

the CPSA, as amended by section 102(b) 

of the Consumer Product Safety 

Improvement Act of 2008 (‘‘CPSIA’’). 

DATES: The rule will become effective 

on February 8, 2013 and applies to 

products manufactured after that date. 

The incorporation by reference of the 

publications listed in this rule is 

approved by the Director of the Federal 

Register as of February 8, 2013.1

FOR FURTHER INFORMATION CONTACT: 

Randy Butturini, Project Manager, 

Office of Hazard Identification and 

Reduction, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, Maryland 20814; 

(301) 504–7562; email: 

RButturini@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Purpose of the Final Rule 

The purpose of this final rule is to 

reduce the incidents of deaths and 

injuries associated with children’s 

products. This will be accomplished by 

increasing the safety of children’s 

products. The likelihood of a 

noncompliant product being detected 

before it is introduced to the public will 

be increased. Consequently, consumer 

confidence in children’s products 

certified to comply with the applicable 

product safety rules may be increased. 

Potentially, the number of recalls for 

children’s products could be reduced, 

and, with continued assessment of 

compliance, the scope of necessary 

recalls could be reduced. Further, third 

party testing during continuing 

production or importation can serve as 

an objective assessment of the 

effectiveness of a manufacturer’s or 

importer’s internal processes to ensure 

compliance, which would also serve to 

enhance the safety of children’s 

products in the market. 

II. Statutory Authority 

A. The Consumer Product Safety Act, as 

Amended by the Consumer Product 

Safety Improvement Act of 2008 

Section 14(a)(1) of the CPSA, (15 

U.S.C. 2063(a)(1)), as amended by 

section 102 of the CPSIA, establishes 

requirements for the testing and 

certification of products subject to a 

consumer product safety rule under the 

CPSA or similar rule, ban, standard, or 

regulation under any other act enforced 

by the Commission and which are 

imported for consumption or 

warehousing or distributed in 

commerce. Under section 14(a)(1)(A) of 

the CPSA, manufacturers and private 

labelers must issue a certificate, which 

‘‘shall certify, based on a test of each 

product or upon a reasonable testing 

program, that such product complies 

with all rules, bans, standards, or 

regulations applicable to the product 

under the CPSA or any other Act 

enforced by the Commission.’’ CPSC 

regulations, at 16 CFR part 1110, limit 

the certificate requirement to importers 

and domestic manufacturers. Section 

14(a)(1)(B) of the CPSA further requires 

that the certificate provided by the 

importer or domestic manufacturer 

‘‘specify each such rule, ban, standard, 

or regulation applicable to the product.’’ 

The certificate described in section 

14(a)(1) of the CPSA is known as a 

General Conformity Certification (GCC). 

Section 14(a)(2) of the CPSA (15 

U.S.C. 2063(a)(2)) establishes testing 

requirements for children’s products 

that are subject to a children’s product 

safety rule. (Section 3(a)(2) of the CPSA 

(15 U.S.C. 2052(a)(2)) defines a 

children’s product, in part, as a 

consumer product designed or intended 

primarily for children 12 years of age or 

younger.) Section 14(a)(2)(A) of the 

CPSA also states that, before a 

children’s product subject to a 

children’s product safety rule is 

imported for consumption or 

warehousing or distributed in 

commerce, the manufacturer or private 

labeler of such children’s product must 

submit sufficient samples of the 

children’s product ‘‘or samples that are 

identical in all material respects to the 

product’’ to an accredited ‘‘third party 

conformity assessment body’’ to be 

tested for compliance with the 

children’s product safety rule. Based on 

such testing, the manufacturer or private 

labeler, under section 14(a)(2)(B) of the 

CPSA, must issue a certificate that 

certifies that such children’s product 

complies with the children’s product 

safety rule based on the assessment of 

a third party conformity assessment 

body accredited to perform such tests. 

Section 14(i)(2)(A) of the CPSA 

requires the Commission to initiate a 

program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements. This 

provision applies to all consumer 

products that are subject to a product 

safety rule administered by the 

Commission. (On August 12, 2011, the 

President signed into law H.R. 2715, 

which amended both the CPSA and the 

CPSIA. Section 10(a) of H.R. 2715 

redesignates what was identified as 

section 14(d) of the CPSA in the 

preamble of the proposed rule as section 

14(i) of the CPSA; consequently, except 

where we are citing language from the 

proposed rule, the remainder of this 

document will refer to section 14(i) of 

the CPSA.) 

Section 14(i)(2)(B) of the CPSA 

requires the Commission to establish 

protocols and standards for: 

• Ensuring that a children’s product 

tested for compliance with a children’s 

product safety rule is subject to testing 

periodically and when there has been a 

material change in the product’s design 

or manufacturing process, including the 

sourcing of component parts; 

• Testing of representative samples; 

• Verifying that a children’s product 

tested by a conformity assessment body 

complies with applicable children’s 

product safety rules; and 

• Safeguarding against the exercise of 

undue influence on a third party 

conformity assessment body by a 

manufacturer or private labeler. 

Section 14(i)(2)(B)(iii) of the CPSA 

provides for verification that a 

children’s product tested by a 

conformity assessment body complies 

with applicable children’s product 

safety rules. At this time, we are not 

imposing any verification obligations on 

manufacturers because we intend to 

conduct the verification ourselves under 

our inherent authorities while we gain 

more experience with the testing and 

certification requirements. When we 

find that a children’s product 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69483 

accompanied by a certificate of 

conformity does not pass the tests upon 

which the certification was based, we 

may initiate an investigation of the 

manufacturer, third party conformity 

assessment body, and any other relevant 

party in the supply chain, to determine 

the cause of the discrepancy. 

To implement sections 14(a) and (d) 

(now renumbered by H.R. 2715 as 

section 14(i)) of the CPSA, as amended 

by section 102 of the CPSIA, we 

published a proposed rule in the 

Federal Register on May 20, 2010 (75 

FR 28336). The proposed rule would: 

• Define the elements of a 

‘‘reasonable testing program’’ for 

purposes of section 14(a)(1)(A) of the 

CPSA; 

• Establish the protocols and 

standards for continuing testing of 

children’s products under section 

14(d)(2)(B)(i), (ii), and (iv) (renumbered 

as sections 14(i)(2)(B)(i), (ii), and (iv)) of 

the CPSA; and 

• Describe the label that 

manufacturers may place on a consumer 

product to show that the product 

complies with the certification 

requirements for purposes of what was 

numbered previously as section 

14(d)(2)(A) of the CPSA (now 

renumbered by H.R. 2715 as section 

14(i)(2)(A) of the CPSA). 

B. H.R. 2715 and Its Impact on This 

Rulemaking 

On August 12, 2011, the President 

signed into law H.R. 2715. H.R. 2715 

amended the CPSA and the CPSIA in 

several ways. For example, section 2, 

‘‘Application of Third Party Testing 

Requirements,’’ of H.R. 2715, revised 

section 14(d) of the CPSA, in part, by: 

• Renumbering the second paragraph 

of section 14(d) of the CPSA as section 

14(i) of the CPSA. (When the CPSIA was 

enacted, it created, mistakenly, two 

paragraph (d)s in section 14 of the 

CPSA. The paragraph at issue in the 

proposed rule was the second of the two 

paragraphs numbered (d); H.R. 2715 

contained a technical amendment to 

renumber the second paragraph (d) as a 

new paragraph (i) of section 14 of the 

CPSA); 

• Revising section 14(i)(2)(B)(ii) of the 

CPSA to require the testing of 

‘‘representative samples,’’ rather than 

the testing of ‘‘random samples’’; 

• Creating a new section 14(i)(3)(A) of 

the CPSA requiring, no later than 60 

days after the date of enactment, that we 

‘‘seek public comment on opportunities 

to reduce the cost of third party testing 

requirements consistent with assuring 

compliance with any applicable 

consumer product safety rule, ban, 

standard, or regulation.’’ H.R. 2715 lists 

seven topics for public comment: 

Æ The extent to which the use of 

materials subject to regulations of 

another government agency that 

requires third party testing of those 

materials may provide sufficient 

assurance of conformity with an 

applicable consumer product safety 

rule, ban, standard, or regulation 

without further third party testing; 

Æ The extent to which modification of 

the certification requirements may have 

the effect of reducing redundant third 

party testing by or on behalf of 2 or 

more importers of a product that is 

substantially similar or identical in all 

material respects; 

Æ The extent to which products with 

a substantial number of different 

components subject to third party 

testing may be evaluated to show 

compliance with an applicable rule, 

ban, standard, or regulation by third 

party testing of a subset of such 

components selected by a third party 

conformity assessment body; 

Æ The extent to which manufacturers 

with a substantial number of 

substantially similar products subject to 

third party testing may reasonably make 

use of sampling procedures that reduce 

the overall test burden without 

compromising the benefits of third party 

testing; 

Æ The extent to which evidence of 

conformity with other national or 

international governmental standards 

may provide assurance of conformity to 

consumer product safety rules, bans, 

standards, or regulations applicable 

under the CPSA; 

Æ The extent to which technology, 

other than the technology already 

approved by the Commission, exists for 

third party conformity assessment 

bodies to test or to screen for testing 

consumer products subject to a third 

party testing requirement; and 

Æ Other techniques for lowering the 

cost of third party testing consistent 

with assuring compliance with the 

applicable consumer product safety 

rules, bans, standards, and regulations. 

• Creating a new section 14(i)(3)(B) of 

the CPSA, requiring us to review the 

public comments and stating that we 

‘‘may prescribe new or revised third 

party testing regulations if [we 

determine] that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations; and 

• Creating a new section 14(i)(4) of 

the CPSA, titled, ‘‘Special rules for 

small batch manufacturers,’’ to provide 

‘‘alternative testing requirements’’ for 

‘‘covered products’’ manufactured by 

small batch manufacturers or to exempt 

small batch manufacturers from third 

party testing requirements. H.R. 2715 

defines a ‘‘covered product’’ as ‘‘a 

consumer product manufactured by a 

small batch manufacturer where no 

more than 7,500 units of the same 

product were manufactured in the 

previous calendar year.’’ It defines a 

‘‘small batch manufacturer,’’ in part, as 

‘‘a manufacturer that had no more than 

$1,000,000 in total gross revenue from 

sales of all consumer products in the 

previous calendar year.’’ 

H.R. 2715 also contains (among other 

things) provisions on registration of 

small batch manufacturers and 

exclusions of certain materials from 

third party testing. For example, H.R. 

2715 created a new section 14(i)(5)(A)(i) 

of the CPSA, which states that the third 

party testing requirements do not apply 

to ‘‘ordinary books or ordinary paperbased printed materials.’’ 

The Commission has chosen to 

finalize those parts of the proposed rule 

that were not affected directly or 

significantly by H.R. 2715, and we will 

reserve other subparts or provisions in 

the final rule, pending our consideration 

and implementation of H.R. 2715. For 

example, because section 14(i)(2)(B)(ii) 

of the CPSA, as amended by H.R. 2715, 

now refers to the testing of 

‘‘representative samples,’’ we have 

decided to remove § 1107.22 from 

subpart C of the final rule, which would 

have pertained to ‘‘Random Samples.’’ 

III. Comments on the Proposed Rule 

and Our Responses 

Below, we describe and explain each 

subpart and section of the final rule, as 

well as describe and respond to the 

comments on the proposed rule. A 

summary of each of the commenters’ 

topics is presented, and each topic is 

followed by our response. For ease of 

reading, each comment will be prefaced 

by a numbered ‘‘Comment’’; and each 

response will be prefaced by a 

corresponding numbered ‘‘Response.’’ 

Each ‘‘Comment’’ is numbered to help 

distinguish between different topics. 

The number assigned to each comment 

is for organizational purposes only and 

does not signify the comment’s value or 

importance or the order in which it was 

received. Comments on similar topics 

are grouped together. 

A. General Comments 

Several commenters addressed issues 

regarding testing and costs, generally. 

(Comment 1)—One commenter 

warned that because the overwhelming 

majority of consumer products sold in 

the United States are produced overseas, 


emcdonald on DSK5VPTVN1PROD with RULES3
69484 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

2 It should be noted, however, that although we 

are not finalizing subpart B at this time, 

manufacturers of non-children’s products that are 

subject to a product safety rule, ban, standard, or 

regulation are still obligated by the CPSA, as 

amended by the CPSIA, to certify that their 

products comply with all applicable safety rule[s] 

based on a test of each product or a reasonable 

testing program. 

nearly all of the work necessary to 

ensure compliance with the regulations 

will be performed overseas. The 

commenter stated that because the cost 

of compliance for foreign manufacturers 

can be relatively high—while the risks 

associated with noncompliance can be 

relatively low—it is important that our 

regulation balance the need for a high 

degree of assurance of compliance 

against the need to develop a practical 

regulatory structure that foreign 

manufacturers can and will implement. 

(Response 1)—The final rule is 

designed not to be overly prescriptive, 

thereby giving manufacturers some 

flexibility in designing their testing and 

certification programs to be consistent 

with the statutory requirements. For 

example, the final rule allows the 

manufacturer to determine the number 

of samples that are tested, as long as the 

manufacturer has a high degree of 

assurance that the products represented 

by the samples are in compliance with 

all applicable children’s product safety 

rules. Further, while the final rule 

requires that manufacturers document 

their compliance, it gives manufacturers 

the flexibility to determine how to 

maintain this information. In addition, 

the final rule does not require any 

documentation to be maintained in 

English or kept in the United States, 

except the certificate. 

We also note that, on August 12, 2011, 

the President signed into law H.R. 2715, 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. H.R. 

2715 directs us to seek public comment 

on seven specific issues, including the 

extent to which modification of the 

certification requirements may have the 

effect of reducing redundant third party 

testing by or on behalf of two or more 

importers of a product that is 

substantially similar or identical in all 

material respects, and other techniques 

for lowering the cost of third party 

testing consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. Elsewhere in 

this issue of the Federal Register, we 

have published a notice seeking public 

comment on the issues in H.R. 2715. 

H.R. 2715 further requires us to review 

the public comments and states that we 

may prescribe new or revised third 

party testing regulations if we determine 

that such regulations will reduce third 

party testing costs consistent with 

assuring compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 

(Comment 2)—Two commenters 

stated that we should conduct a full 

cost-benefit analysis of the rule. One 

commenter added that costs of 

complying with the testing and 

certification rule, in combination with 

other requirements under the CPSIA 

and other rules administered by the 

CPSC, will result in a major rule with 

major implications to consumer product 

manufacturers, particularly children’s 

product manufacturers, as well as to the 

entire supply chain. The commenter 

urged us to examine in greater detail, 

and to quantify, the full cost and burden 

of these rules. A third commenter 

implored us to consider the reduction in 

risk, if any, associated with each 

regulatory requirement and impose only 

those requirements that meaningfully 

enhance consumer safety in a way that 

makes increased costs and use of 

resources worthwhile. 

(Response 2)—This rule is being 

promulgated under the Administrative 

Procedure Act and also section 3 of the 

CPSIA; neither authority requires us to 

conduct a cost-benefit analysis. 

Moreover, by allowing in CPSIA 

expedited rulemaking, Congress made it 

clear that it did not want the 

Commission engaging in any 

unnecessary delay in promulgating this 

rule. However, we agree that the final 

rule constitutes a major rule, as defined 

by the Congressional Review Act of 

1996. While, in recognition of 

Congress’s view as reflected in CPSIA, 

we decline to conduct a cost-benefit 

analysis for the final rule, we have 

changed the final rule to address some 

of the economic burden on 

manufacturers. Among the changes 

made to the final rule to reduce the 

burden are: (1) Reserving the subpart B 

requirements regarding a reasonable 

testing program; 2 (2) eliminating certain 

requirements of the proposed rule for 

children’s products such as the remedial 

action plan; (3) reducing the 

recordkeeping requirements in several 

respects; and (4) allowing the use of inhouse ISO/IEC 17025:2005 laboratories 

to reduce the frequency of third party 

periodic testing. By way of further 

example, with regard to the reduction in 

the recordkeeping requirements, the 

final rule does not require records to be 

kept in the United States, nor does it 

require records to be translated into 

English, unless requested. 

Additionally, we note that a costbenefit analysis would not necessarily 

be confined to manufacturers or those in 

a supply chain (as implied by one 

commenter). We expect, for instance, 

that consumers will benefit from the 

testing and certification of consumer 

products, particularly if such testing 

revealed potential problems associated 

with a product or its components, or if 

such testing prompted a manufacturer to 

redesign or remanufacture the product 

to make it safer. 

(Comment 3)—One commenter stated 

that some retailers are requiring many 

manufacturers to submit their products 

to as many as four different laboratories 

because the retailers want to see test 

results from specific laboratories. The 

commenter stated that we should clarify 

to retailers that this redundant testing is 

not necessary. 

(Response 3)—The preamble to the 

proposed rule stated that retailers and 

sellers of children’s products can rely 

on certificates provided by finished 

product certifiers—without conducting 

additional testing themselves—if those 

certificates are based on testing 

conducted by a CPSC-accepted third 

party conformity assessment body (75 

FR at 28337). 

B. Proposed Subpart A—General 

Provisions 

1. Proposed § 1107.1—Purpose 

Proposed § 1107.1 would state that 

part 1107 establishes the requirements 

for a reasonable testing program for nonchildren’s products; third party 

conformity assessment body testing to 

support certification and continuing 

testing of children’s products; and 

labeling of consumer products to 

indicate that the certification 

requirements have been met pursuant to 

sections 14(a)(1), and (a)(2), (d)(2)(B) of 

the CPSA (15 U.S.C. 2063(a)(1), (a)(2), 

(d)(2)(B)). 

We did not receive any comments on 

this section. However, because we have 

decided to reserve subpart B, which 

would pertain to the reasonable testing 

program for non-children’s products, we 

have removed the reference to the 

‘‘reasonable testing program for nonchildren’s products.’’ (We explain our 

decision to reserve subpart B of the 

proposed rule in part B.2 of this 

preamble below.) 

Additionally, because H.R. 2715 

revised section 14(i)(2)(B)(ii) of the 

CPSA to refer to testing of 

‘‘representative’’ rather than ‘‘random’’ 

samples, we have, on our own initiative, 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69485 

elected to simplify § 1107.1 to reflect the 

final rule’s narrower purpose and have 

made minor, non-substantive changes to 

follow the language of the statute. This 

helps clarify which requirements in the 

statute this final rule is intended to 

address and which have been reserved 

for a later date. Additionally, proposed 

§ 1107.1 was silent regarding procedures 

to safeguard against the exercise of 

undue influence by a manufacturer on 

a third party conformity assessment 

body, even though proposed § 1107.24, 

‘‘Undue influence,’’ would contain such 

safeguards. Consequently, the final rule 

now mentions the establishment of 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. Thus, 

§ 1107.1 now states that the part 

establishes the protocols and standards 

for ensuring continued testing of 

children’s products periodically and 

when there has been a material change 

in the product’s design or 

manufacturing process and safeguarding 

against the exercise of undue influence 

by a manufacturer on a third party 

conformity assessment body. It also 

establishes a program for labeling of 

consumer products to indicate that the 

certification requirements have been 

met pursuant to sections 14(a)(2) and 

(i)(2)(B) of the Consumer Product Safety 

Act (CPSA) (15 U.S.C. 2063(a)(2) and 

(i)(2)(B)). 

2. Proposed § 1107.2—Definitions 

Proposed § 1107.2 would define 

various terms used in the rule. 

a. CPSA 

Proposed § 1107.2 would define 

‘‘CPSA’’ to mean the Consumer Product 

Safety Act. 

We received no comments on this 

definition and have finalized it without 

change. 

b. CPSC 

Proposed § 1107.2 would define 

‘‘CPSC’’ to mean the Consumer Product 

Safety Commission. 

We received no comments on this 

definition and have finalized it without 

change. 

c. CPSIA 

Proposed § 1107.2 would define 

‘‘CPSIA’’ to mean the Consumer Product 

Safety Improvement Act of 2008. 

We received no comments on this 

definition and have finalized it without 

change. 

d. Detailed Bill of Materials 

Proposed § 1107.2 would define 

‘‘detailed bill of materials’’ to mean a 

list of the raw materials, subassemblies, 

intermediate assemblies, subcomponent 

parts, component parts, and the 

quantities of each needed to 

manufacture a finished product. 

We received no comments on this 

definition. However, because the term 

‘‘detailed bill of materials’’ appeared 

only in proposed § 1107.10(b)(1) (which 

would require a product specification as 

part of the reasonable testing program), 

and because the final rule now reserves 

subpart B, we have removed the 

definition of ‘‘detailed bill of materials’’ 

from the final rule. 

e. Due Care 

Proposed § 1107.2 would define ‘‘due 

care’’ to mean the degree of care that a 

prudent and competent person engaged 

in the same line of business or endeavor 

would exercise under similar 

circumstances. 

(Comment 4)—One commenter noted 

that the due care requirement only 

applies to a few specific provisions of 

the proposed rule, such as proposed 

§ 1107.23(a) regarding ‘‘material 

change’’ in the product’s design, 

manufacturing process, or sourcing of 

component parts. In some instances, 

this defined duty of ‘‘due care’’ would 

be coupled with a CPSC-created 

standard of ‘‘high degree of assurance.’’ 

The commenter appreciated our 

recognition that both the ‘‘due care’’ 

standard of conduct and the ‘‘high 

degree of assurance’’ standard for 

compliance are anchored in the 

judgment and knowledge of the 

manufacturer. For that reason, the 

commenter felt that the due care 

requirement should have general 

applicability to all elements of 

compliance for implementation of the 

CPSIA’s testing and certification 

requirements. The commenter stated 

that manufacturers should not have to 

wonder whether more than their 

exercise of reasonable judgment and 

practice, based on their manufacturing 

experience and sound knowledge of the 

product, is required for aspects of the 

rules that do not explicitly reference 

these standards. 

(Response 4)—The definition of ‘‘due 

care’’ in § 1107.2 refers to the actions of 

a prudent and competent person. We 

expect that all parties will exercise 

prudence and competence in the testing 

and certification of products. The final 

rule emphasizes due care in particular 

sections, as noted by the commenter, 

because these are areas that require 

additional care in order to prevent 

noncompliant products from being 

produced and certified. 

We recognize that manufacturers’ 

knowledge of their products and their 

manufacture can serve as a basis for 

determining what steps are necessary to 

achieve a high degree of assurance that 

their products comply with the 

applicable product safety rules. Based 

on that knowledge, manufacturers are 

uniquely situated to know what actions 

are necessary to exercise due care and 

demonstrate a high degree of assurance 

regarding their specific circumstances. 

On our own initiative, we have 

revised the definition of ‘‘due care’’ in 

the final rule. The final rule’s definition 

of ‘‘due care’’ includes a sentence 

stating that ‘‘Due care does not permit 

willful ignorance.’’ This is not intended 

to be a substantive change because any 

party who is willfully ignorant of 

material facts, by definition, would not 

be exercising due care. However, the 

Commission wants to emphasize in the 

final rule that a party cannot purposely 

avoid knowing their business partner’s 

testing and certification practices to 

avoid violating section 19 of the CPSA. 

A party will not be shielded from 

violating section 19 of the CPSA when 

that party knows or should know about 

testing and/or certification problems 

which may affect the ability of a 

consumer product to be compliant with 

all rules, bans, standards, or regulations. 

Certifiers and testing parties have an 

obligation to resolve known or 

knowable problems with testing and/or 

certification before relying upon or 

passing on test reports or certifications. 

f. High Degree of Assurance 

Proposed § 1107.2 would define ‘‘high 

degree of assurance’’ as ‘‘an evidencebased demonstration of consistent 

performance of a product regarding 

compliance based on knowledge of a 

product and its manufacture.’’ 

(Comment 5)—Multiple commenters 

questioned the definition of a ‘‘high 

degree of assurance.’’ One commenter 

would like the rule to define the term 

‘‘high degree of assurance’’ in a more 

understandable or quantitative way. The 

commenter considered the term to be 

confusing and misleading and believed 

this could lead to unnecessary conflicts 

between manufacturers and conformity 

assessment bodies when a judgment has 

to be made in certain cases. The 

commenter wondered if this 

requirement is targeting the design area, 

manufacturing process control, quality 

control, or testing procedures. 

Another commenter said that 

manufacturers would benefit from 

additional guidance on how to achieve 

a ‘‘high degree of assurance’’ through 

their testing programs. The preamble to 

the proposed rule referred to a 95 

percent statistical significance level as 

constituting a ‘‘high degree’’ of 


emcdonald on DSK5VPTVN1PROD with RULES3
69486 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

assurance, but the proposed rule would 

not mandate a 95 percent confidence 

threshold. The commenter asked what 

factors would permit a manufacturer to 

satisfy the ‘‘high degree of assurance’’ 

requirement with a statistical 

significance level below 95 percent and 

asked us to provide an example of a 

situation where a manufacturer could 

still achieve a high degree of assurance 

with less than 95 percent assurance. 

Another commenter argued that the 

term ‘‘high degree of assurance’’ is 

subjective and subject to varied 

interpretations. The commenter 

suggested that a statistical confidence 

limit would help remove the 

subjectivity and set a specific threshold 

by which we can enforce our rules 

better. The commenter also was 

concerned that the wording may lead 

some manufacturers to believe that they 

do not have to test to the standard in all 

cases, as long as they foresee little risk 

of noncompliance, or assume that the 

risk is low of being discovered having 

noncompliant products in the 

marketplace. The commenter said the 

final rule should clarify that testing to 

applicable standards is required. 

(Response 5)—The determination of a 

‘‘high degree of assurance’’ for a given 

product will vary by industry, product, 

component part, and by manufacturer. 

Therefore, selecting an example using a 

hypothetical certifier would be of little 

value to manufacturers. We have 

intentionally defined the term in a 

manner that allows the manufacturer 

the flexibility to develop a testing 

program to ensure their product 

complies with all applicable children’s 

product safety rules. This rule provides 

broad protocols and standards for 

regulated firms to follow and adapt to 

their particularized needs given their 

products and processes. The use of 

quantitative values for the definition of 

‘‘high degree of assurance’’ could lead to 

difficulties for some manufacturers. The 

preamble to the proposed rule stated: 

‘‘We decided against defining ‘high 

degree of assurance’ with respect to a 95 

percent probability or confidence level 

because there may be difficulty in 

applying the statistical methods to all 

manufacturing processes’’ (75 FR 

28344). The intent of the definition is to 

enable a manufacturer to have a degree 

of confidence, based on evidence (rather 

than only on a belief) that all of the 

products manufactured are compliant 

with the applicable product safety rules. 

Knowledge of a product’s design and 

how it is manufactured, control over 

component parts, and measurements 

showing consistent performance, are 

some elements that can be used to 

demonstrate a ‘‘high degree of 

assurance.’’ 

As for the commenter asking us to 

clarify that testing to applicable 

standards is required, § 1107.20 (a) of 

the final rule states that manufacturers 

must submit samples of a children’s 

product to a third party conformity 

assessment body for testing. We believe 

these statements are clear enough to 

convey that certification testing involves 

tests. 

(Comment 6)—Two commenters 

agreed that a numerical target for 

defining what constitutes a high degree 

of assurance—in the context of 

programs based on good manufacturing 

practices (GMP)—is misplaced. One 

commenter noted that the explanation 

of the definition of ‘‘high degree of 

assurance’’ provided in the preamble to 

the proposed rule (75 FR at 28344) 

implies that we prefer the 95 percent 

statistical level of confidence for a highdegree-of-assurance approach and 

consider it the default. The commenter 

is concerned that the 95-percentconfidence-level language may prompt 

third party conformity assessment 

bodies and retailers to adopt 

standardized testing protocols that 

demand large sample sizes, which will 

be a particular burden for the initial 

certification and may not be warranted 

in many cases. The commenter 

expressed the belief that the goal, across 

a broad range of different products that 

are subject to different manufacturing 

requirements and material sourcing, 

must be a standard that correlates ‘‘a 

high degree of assurance’’ with an 

‘‘evidence-based demonstration of 

consistent performance’’ that relies 

more appropriately upon process 

controls to assure conformance. The 

commenter indicated that, while 

generally accepted process controls may 

include statistical sampling as part of 

process control programs, in and of 

themselves, they are not preferable to 

good manufacturing practices. The 

commenter said that the final rule must 

be clear in this regard. 

(Response 6)—Standards for GMPs are 

generally industry-specific in areas such 

as: Cosmetics, pharmaceutical 

operations, food handling, and medical 

devices. It is unlikely that any GMPbased program would be deemed 

workable or acceptable for all children’s 

product manufacturing methods. 

A certifier’s determination that a 

product complies—with a high degree 

of assurance—with the applicable 

children’s product safety rules, may 

derive from statistically based testing, 

the application of good manufacturing 

practices, or other knowledge of the 

product and its manufacture. Because 

GMP-based programs are industryspecific, we disagree with the 

commenter’s assertion that the programs 

are preferable to other accepted process 

controls in all manufacturing situations. 

The final rule defines a ‘‘high degree 

of assurance’’ in general terms because 

the definition is intended to be applied 

to a wide variety of products that use 

many different manufacturing 

processes. Customizing the definition of 

‘‘high degree of assurance’’ to fit one 

type of product or GMP-based program 

will necessarily increase the difficulty 

of manufacturers applying the definition 

to dissimilar products or manufacturing 

processes. Further, because GMP-based 

programs vary across industries—and 

the comments were not specific about 

which aspect(s) of a GMP program we 

should adopt, or which GMPs we 

should adopt—we cannot revise the 

definition, as requested by the 

commenter. 

As for the commenter who interpreted 

the preamble to the proposed rule as 

expressing a preference for a 95 percent 

confidence level, we do not consider a 

numerically based definition of a ‘‘high 

degree of assurance’’ to be the default 

position. Defining a ‘‘high degree of 

assurance’’ with respect to a 95 percent 

probability or confidence level would be 

difficult to apply to all manufacturing 

processes for children’s products. 

Defining a ‘‘high degree of assurance’’ as 

a 95 percent, or higher, probability or 

confidence level could result in greater 

testing demands on small 

manufacturers. As discussed in the 

preamble of the proposed rule (75 FR at 

28344), a statistical definition is not 

needed in order to provide an evidencebased high degree of assurance. 

Regarding the concern that conformity 

assessment bodies and retailers may 

require large numbers of samples for 

certification testing, the children’s 

product certifier (not the conformity 

assessment body or retailer) specifies 

the number of samples to be tested. The 

final rule requires the number of 

samples to be sufficient to give the 

certifier a high degree of assurance that 

the tests conducted demonstrate 

accurately the ability of the product to 

comply with the applicable children’s 

product safety rules. As we previously 

stated in the preamble to the proposed 

rule: 

The Commission wants to emphasize to 

retailers and sellers of children’s products 

that they can rely on certificates provided by 

product suppliers if those certificates are 

based on testing conducted by a third party 

conformity assessment body. 

75 FR at 28337. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69487 

(Comment 7)—Two commenters 

contended that the proposed definition 

of a ‘‘high degree of assurance’’ lacks 

clarity. Both commenters said that the 

rule should have additional examples of 

what constitutes ‘‘a high degree of 

assurance.’’ One commenter 

acknowledged that the discussion in the 

preamble to the proposed rule makes 

clear that the definition mandates no 

specific formula (75 FR at 28344). 

However, the commenter noted that the 

preamble to the proposed rule gave no 

specific examples, other than the use of 

statistical methods. The commenter 

argued that the final rule should 

recognize other means of achieving this 

confidence level, including ways that do 

not rely solely on product testing or 

statistical methods. These methods 

include appropriate quality assurance 

processes and risk management. Quality 

assurance processes can include: 

Factory/supplier evaluations, design 

reviews, manufacturing process 

controls, process auditing, or similar 

controls or reviews. Risk management 

includes: Analysis of a given possible 

failure, the likelihood of the failure, and 

the potential consequences associated 

with the failure. The commenter argued 

that importers can use these activities to 

boost desired outcomes and reduce 

unexpected outcomes; and the 

commenter further maintained that the 

activities can be performed in a 

feedback loop that facilitates true rootcause analysis and correction, if there is 

a failure. 

The commenters suggested substitute 

definitions for ‘‘a high degree of 

assurance’’ that are practically identical. 

One suggested definition reads: ‘‘A high 

degree of assurance means an evidencebased determination of consistent 

performance of a product regarding 

compliance based on knowledge of a 

product and its manufacture.’’ 

Acceptable evidence-based 

determinations may be based on 

evidence derived through any 

appropriate process or control or 

combination of processes and/or 

controls, such as (but not limited to): 

• Design validation; 

• Manufacturing process control 

audits; 

• In-process manufacturing controls, 

measurements, and tests; 

• Component and material testing, as 

defined in 16 CFR part 1109; 

• Finished product testing; 

• Raw materials certification; and 

• Other controls or processes that 

provide information about the safety or 

compliance of a product. 

The other commenter’s suggested 

definition reads: ‘‘High degree of 

assurance means an evidence-based 

determination of consistent performance 

of a product regarding compliance based 

on knowledge of a product and its 

manufacture. Acceptable determinations 

may be based on evidence derived 

through any appropriate tool or control 

methodology (or combination of tools 

and/or control methodologies), such as 

but not limited to: 

• Design Validation 

• Process Validation 

• Manufacturing Process Control 

Audits 

• Raw material validation and 

controls 

• In-process manufacturing controls, 

measurements, and tests 

• Component and material testing as 

defined at 16 CFR part 1109 

• Finished Product Testing’’ 

(Response 7)—The commenters are 

correct that certifiers can use process 

controls, mathematical techniques, 

simulations, and other aspects of a 

product and its manufacture, as part of 

the basis for determining whether a 

particular product complies with the 

applicable product safety rules with a 

high degree of assurance. The 

commenters also are correct that the 

preamble to the proposed rule (75 FR at 

28344) provided statistically based 

examples in the definition of a ‘‘high 

degree of assurance.’’ However, a 

method on the commenters’ list may be 

adequate for one rule, but inadequate for 

another. As an example, Design 

Validation may be a good technique to 

ensure that a toy does not have a hole 

large enough to allow access to a sharp 

edge or point. However, Design 

Validation may be inadequate for 

controlling lead content because its 

techniques are ill-suited for controlling 

continuing production of component 

parts. As another example, component 

part testing is a useful technique for 

determining the chemical content of 

lead and the prohibited phthalates, but 

it is inadequate for determining 

compliance to the pacifier pull tests 

because the entire product is required to 

conduct the test. ‘‘A high degree of 

assurance’’ is defined in general terms 

because it is intended to be applied to 

a wide variety of products that use 

many different manufacturing 

processes. Providing a list of the 

intended applications as part of the 

definition would introduce the risk of a 

manufacturer applying techniques that 

are inappropriate for evaluating the 

applicable children’s product safety 

rule. 

Therefore, we decline to amend the 

definition of ‘‘a high degree of 

assurance,’’ as suggested by the 

commenters. Specific examples are not 

universally applicable; and therefore, 

they should not be included in the 

definition of ‘‘a high degree of 

assurance.’’ Any such list necessarily 

would be underinclusive or possibly 

confusing or misleading. Additionally, 

certification and periodic testing of 

children’s products must be based on 

tests of the finished product, or its 

component parts, sufficient to show 

compliance (or continuing compliance, 

in the case of periodic testing) with all 

applicable children’s product safety 

rules. A definition of a ‘‘high degree of 

assurance,’’ that includes methods other 

than testing, might lead some certifiers 

to conclude mistakenly that certification 

or periodic test requirements might be 

met by means other than testing. 

(Comment 8)—One commenter 

suggested that the final rule allow a 

company’s prior safety record to replace 

product safety testing as evidence that a 

company has met the requirement for a 

high degree of assurance (‘‘HDA’’). The 

commenter wrote: 

The ‘‘high degree of assurance’’ should be 

based on an overall assessment of the safety 

record of the company. It should NOT be 

based on the results of an individual product, 

even if recalled or deemed dangerous. 

The commenter pointed out that its 

company had a very good safety record. 

The commenter added: 

With this record over so many years, our 

company should be deemed to have satisfied 

this HDA requirement and be endorsed as 

having a reasonable testing program without 

further inquiry. 

(Response 8)—Section 14(a)(2) of the 

CPSA makes clear that children’s 

product certification is based upon third 

party testing of the product and not a 

company’s safety record. For this 

reason, the final rule does not provide 

relief from the testing requirements in 

the statute. In addition, the commenter’s 

suggestion that a manufacturer should 

be allowed to rely upon its prior safety 

record to demonstrate a high degree of 

assurance would be a difficult concept 

to apply in practice because of the likely 

changes in any given manufacturer’s 

safety record over time and potential 

disagreements as to whether a product 

caused a safety problem, whether the 

safety problem resulted from product 

misuse, and whether safety issues had 

to occur at a particular rate of frequency 

before testing was warranted. 

(Comment 9)—One commenter stated 

that a ‘‘high degree of assurance’’ could 

be provided best by using an accredited 

product certification program that meets 

the requirements of the International 

Standards Organization/International 

Electrotechnical Commission (ISO/IEC) 

Guide 65, General requirements for 

bodies operating product certification 


emcdonald on DSK5VPTVN1PROD with RULES3
69488 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

systems, and the fundamentals of 

System 5 product certification 

requirements of ISO/IEC Guide 67, 

Conformity assessment—Fundamentals 

of product certification. 

(Response 9)—The various activities a 

certification body undertakes, such as 

testing, conformity assessment, and 

surveillance can be used to demonstrate 

a high degree of assurance that a 

product complies with the applicable 

product safety rules. However, the 

techniques used by certification bodies 

are not the only means a manufacturer 

could use. Process control techniques, 

failure modes and effects analyses, and 

other quality assurance methods, 

depending upon the product under 

consideration, could be as effective as 

certification body methods. Because we 

want to give certifiers the flexibility to 

decide which methods apply best to 

their particular products, we decline to 

define a ‘‘high degree of assurance’’ 

using ISO/IEC Guide 65 and Guide 67 

requirements. A manufacturer who 

wishes to use those requirements to 

ensure a high degree of assurance of 

compliance may do so. However, we 

reiterate that testing in support of 

certification of a children’s product 

must be performed by a CPSC-accepted 

third party conformity assessment body 

whose scope of accreditation includes 

the tests required for certification, and 

certification of a product cannot be 

delegated to another party, such as a 

certification body. 

(Comment 10)—A commenter 

suggested that the language related to 

periodic testing intervals and sample 

sizes is inconsistent in the preamble to 

the proposed rule. The commenter 

conceded that it is difficult to specify 

the exact number of products that must 

be tested in order to reach a high degree 

of assurance that a product is compliant. 

The commenter noted that the response 

to comments section of the preamble to 

the proposed rule titled, Additional 

Third Party Testing Requirements for 

Children’s Products, stated that ‘‘the 

sample size for periodic testing will 

depend upon the number of samples 

that need to be tested to provide that 

statistical assurance’’ (75 FR at 28342). 

The commenter agreed with this 

statement but noted the inconsistency 

between the language used in that 

section and the language found in the 

response to comments section titled, 

The Reasonable Testing Program, which 

specifies that the testing intervals must 

provide ‘‘reasonable assurance’’ that the 

product meets the requirements of the 

applicable product safety rules (75 FR at 

28338). The commenter noted that there 

is a difference between a ‘‘high degree 

of assurance’’ and ‘‘reasonable 

assurance.’’ The commenter expressed 

the belief that the testing program 

should be statistically based, such that 

a confidence level of 95 percent must be 

achieved to indicate compliance. This 

requirement would eliminate the 

possibility of testing only a single 

sample to indicate compliance, the 

commenter asserted. 

(Response 10)—In the preamble to the 

proposed rule, under the response to 

comments section, Additional Third 

Party Testing Requirements for 

Children’s Products (75 FR at 28342), 

we stated the following: 

If a high degree of assurance is interpreted 

to be a statistical likelihood of not producing 

noncompliant products, the sample size for 

periodic testing will depend upon the 

number of samples that need to be tested to 

provide that statistical assurance (italics 

added) * * * 

The word ‘‘that’’ refers to ‘‘a high 

degree of assurance,’’ which appears at 

the beginning of the sentence. With 

respect to the other alleged 

inconsistencies mentioned in the 

comment, it is worth noting that the 

preamble to the proposed rule uses the 

phrase ‘‘high degree of assurance’’ 20 

times; whereas, the codified text of the 

proposed rule does not use the term 

‘‘reasonable assurance’’ at all. The term 

‘‘reasonable assurance’’ appears only 

once in the preamble to the proposed 

rule, in the introduction to the response 

to comments section titled, The 

Reasonable Testing Program, where it is 

listed as one of the previous questions 

that we asked in the Federal Register 

notice announcing the December 2009 

public workshop. 

We also do not agree with the 

commenter that there should be a 

specific probability level (i.e., 95 

percent) in the definition of ‘‘a high 

degree of assurance.’’ As previously 

noted in the preamble to the proposed 

rule (75 FR at 28344), ‘‘we decided 

against defining ‘high degree of 

assurance’ with respect to a 95 percent 

probability or confidence level because 

there may be difficulty in applying the 

statistical methods to all manufacturing 

processes.’’ Many manufacturing 

processes, such as low-volume and 

continuous manufacturing, are ill-suited 

to use a sampling technique for quality 

control purposes. In addition, for smallvolume manufacturers, the number of 

samples required to achieve 95 percent 

confidence could be excessive, even to 

the point of requiring all of the products 

manufactured to be tested. Because the 

final rule’s testing requirements apply to 

a wide variety of products, 

manufacturers, and manufacturing 

processes, the rule must give 

manufacturers the flexibility to 

determine the best way to comply with 

the testing requirements. 

The intent of the definition is for a 

manufacturer to have a high degree of 

assurance based upon evidence (rather 

than only a belief) that all of the 

products manufactured are compliant 

with the applicable safety rules. 

Knowledge of the product’s design and 

how the product is manufactured, 

control over component parts, 

measurements showing consistent or 

inconsistent performance, the associated 

hazard, and many other elements such 

as these, can be used to determine the 

number of samples required for 

certification and for the periodic testing 

intervals, as noted in the final rule. 

g. Identical in All Material Respects 

Proposed § 1107.2 would define 

‘‘identical in all material respects’’ to 

mean that there is no difference with 

respect to compliance to the applicable 

rules between the samples and the 

finished product. 

(Comment 11)—Several commenters 

asked us to clarify the definition of 

‘‘identical in all material respects.’’ One 

commenter said that the definition 

appears absolute in that it does not 

allow any ‘‘difference with respect to 

compliance.’’ The commenter indicated 

that such a definition would make 

testing requirements unnecessarily rigid 

and costly. 

Another commenter contended that 

the definition of ‘‘identical in all 

material respects’’ cannot be absolute. 

One commenter would revise the 

definition to read: ‘‘ ‘Identical in all 

material respects’ means there is no 

difference between the sample and the 

finished product that could affect 

compliance to the applicable rules.’’ 

Another commenter suggested revising 

the definition of ‘‘identical in all 

material respects’’ to mean ‘‘to a high 

degree of assurance, there is no 

difference between the samples and the 

finished product that is material to 

compliance of the applicable rule.’’ One 

commenter suggested that the definition 

of ‘‘identical in all material respects’’ 

should mean ‘‘a manufacturer possess 

[sic] a reasonable belief that, there is no 

difference between the samples and the 

finished product is not materially 

compliant.’’ 

(Response 11)—We do not regard the 

definitions suggested by the 

commenters to be improvements of the 

existing definition of ‘‘identical in all 

material respects.’’ For example, 

defining ‘‘identical in all material 

respects’’ to mean ‘‘there is no 

difference between the sample and the 

finished product that could affect 

compliance to the applicable rules’’ 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69489 

appears to be so similar to the proposed 

definition that adopting the 

commenter’s suggested definition would 

not alter the rule. Samples used for 

certification testing and the finished 

product may be different—just not 

different in any way that would affect 

the sample’s ability to demonstrate 

compliance of the finished product. The 

definition of ‘‘identical in all material 

respects’’ is intended to emphasize that 

if anything other than the finished 

product is subjected to testing, then the 

characteristics of that sample must be 

identical to the testing of the finished 

product, insofar as complying with the 

applicable product safety rule. 

Otherwise, the test may not indicate that 

the finished product, in fact, complies 

with the applicable product safety rule. 

The second definition suggested for 

‘‘identical in all material respects’’ (‘‘To 

a high degree of assurance, there is no 

difference between the samples and the 

finished product that is material to 

compliance of the applicable rule’’) also 

does not emphasize adequately that the 

finished product is what must comply 

with the applicable rules. In addition, 

using the phrase ‘‘to a high degree of 

assurance’’ in describing the similarity 

(with respect to conformance to the 

applicable rules), results in some doubt 

that the samples, in fact, are ‘‘identical 

in all material respects.’’ Further, 

§ 1107.20(a) of the final rule states that 

manufacturers must submit a sufficient 

number of samples of a children’s 

product, or samples that are identical in 

all material respects to the children’s 

product, to a third party conformity 

assessment body for testing to support 

certification. The number of samples 

selected must provide a high degree of 

assurance that the tests conducted for 

certification purposes accurately 

demonstrate the ability of the children’s 

product to meet all applicable children’s 

product safety rules. Using a ‘‘high 

degree of assurance’’ in the definition of 

‘‘samples’’ would involve a double use 

of the term with no corresponding 

increase in clarity. 

In a similar manner, the third 

definition suggested for ‘‘identical in all 

material respects,’’ which uses the 

phrase ‘‘a reasonable belief,’’ introduces 

doubt that the samples are identical to 

the finished product with respect to 

compliance. Additionally, ‘‘a reasonable 

belief’’ standard in the definition would 

result in an inquiry into the state of 

mind of a particular manufacturer and 

could lead to disagreements between the 

CPSC and manufacturers over whether a 

manufacturer’s belief was ‘‘reasonable’’ 

in a specific instance. Further, the 

commenter did not explain or clarify 

their interpretation of the phrase 

‘‘materially compliant’’; the absence of 

such an explanation or interpretation 

would result in additional uncertainty 

in the definition. 

Nevertheless, on our own initiative, 

we have revised the definition of 

‘‘identical in all material respects’’ to 

make minor clarifications to improve 

the definition’s accuracy and 

consistency with the statute. For 

example, the proposed definition would 

refer to ‘‘compliance to the applicable 

rules;’’ the final definition now adds: 

‘‘bans, standards, or regulations’’ after 

‘‘rules,’’ to be more consistent with 

section 14(f)(1) of the CPSA. We also 

have revised the phrase ‘‘between the 

samples and the finished product’’ to 

read: ‘‘between the samples to be tested 

for compliance and the finished product 

distributed in commerce,’’ to reflect 

that, under the final rule, the items that 

must be ‘‘identical in all material 

respects’’ are the samples that are to be 

tested for compliance (as opposed to 

samples that are tested for any other 

purpose) and the product that is 

actually distributed in commerce. 

(Comment 12)—One commenter 

urged us to state that the phrase 

‘‘identical in all material respects’’ is 

intended to be consistent with the 

‘‘objectively reasonable basis’’ standard 

from 16 CFR part 1633, and that we 

would consider individual subordinate 

mattresses that meet the requirements of 

16 CFR 1633 to be ‘‘identical in all 

material respects’’ to the qualified 

prototype to which a specific mattress is 

subordinate. 

(Response 12)—We agree with the 

commenter that ‘‘identical in all 

material respects’’ is consistent with a 

demonstration on an ‘‘objectively 

reasonable basis,’’ as stated in 16 CFR 

§thnsp;1633.4(b)(3). We consider 

individual subordinate mattresses that 

meet the requirements of 16 CFR part 

1633 to be ‘‘identical in all material 

respects’’ to the qualified prototype to 

which a specific mattress is subordinate. 

h. Manufacturer 

Proposed § 1107.2 would define 

‘‘manufacturer’’ as ‘‘the parties 

responsible for certification of a 

consumer product pursuant to 16 CFR 

part 1110.’’ 

We received no comments on this 

definition and have finalized it without 

change. 

i. Manufacturing Process 

Proposed § 1107.2 would define 

‘‘manufacturing process’’ as ‘‘the 

techniques, fixtures, tools, materials, 

and personnel used to create the 

component parts and assemble a 

finished product.’’ 

(Comment 13)—Two commenters 

noted that the proposed definition 

includes ‘‘personnel used to create the 

component parts and assemble a 

finished product.’’ The commenters 

argued that this should not be construed 

to mean that any change in the 

employees who are involved in the 

production of a part or product is 

equivalent to a change in the 

manufacturing process. 

(Response 13)—Regarding the 

commenters’ suggestion on the 

definition of ‘‘manufacturing process,’’ 

the commenters may be confusing a 

change in the manufacturing process 

with a material change that could affect 

compliance to an applicable product 

safety rule. The commenters are partly 

correct that any change in personnel 

involved with a manufacturing process 

does not necessarily constitute a 

material change with respect to the 

product’s compliance. However, for 

manufacturing processes that rely on 

high levels of craftsmanship or technical 

expertise, such a personnel change 

could affect compliance and, therefore, 

might be considered a material change 

to the manufacturing process. 

Therefore, we have finalized the 

definition of ‘‘manufacturing process’’ 

without change. 

j. Production Testing Plan 

Proposed § 1107.2 would define 

‘‘production testing plan’’ as ‘‘a 

document that shows what tests must be 

performed and the frequency at which 

those tests must be performed to 

provide a high degree of assurance that 

the products manufactured after 

certification continue to meet all the 

applicable safety rules.’’ 

We received no comments on this 

definition, but, on our own initiative, 

we have chosen to remove it from the 

final rule. We have removed the 

definition because it is duplicative of 

the description and requirements of ‘‘a 

production testing plan’’ in 

§ 1107.21(c)(2) of the final rule. 

k. Third Party Conformity Assessment 

Body 

Proposed § 1107.2 would define 

‘‘third party conformity assessment 

body’’ to mean a third party conformity 

assessment body recognized by the 

CPSC to conduct certification testing on 

children’s products. 

We received no comments on this 

definition. However, on our own 

initiative, we have revised the definition 

by making editorial changes to describe 

more accurately our accreditation 

process and to indicate that the third 

party conformity assessment body’s 

scope of accreditation must include the 


emcdonald on DSK5VPTVN1PROD with RULES3
69490 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

applicable CPSC-required tests. Thus, 

the final rule now defines ‘‘third party 

conformity assessment body’’ as ‘‘a 

testing laboratory whose accreditation 

has been accepted by the CPSC to 

conduct certification testing on 

children’s products. Only third party 

conformity assessment bodies whose 

scope of accreditation includes the 

applicable required tests can be used for 

children’s product certification or 

periodic testing purposes.’’ 

C. Proposed Subpart B—Reasonable 

Testing Program for Non-Children’s 

Products 

Proposed subpart B would consist of 

one provision and would describe the 

‘‘reasonable testing program’’ for nonchildren’s products. For example, 

proposed § 1107.10(a) would explain 

that, except as otherwise provided by a 

specific CPSC regulation or a specific 

standard prescribed by law, a 

manufacturer certifying a product 

pursuant to a reasonable testing program 

must ensure that the program ‘‘provides 

a high degree of assurance that the 

consumer products covered by the 

program will comply with all applicable 

rules, bans, standards, or regulations.’’ 

Proposed § 1107.10(b) would state that a 

reasonable testing program must consist 

of five elements: (1) Product 

specification; (2) certification tests; (3) a 

production testing plan; (4) a remedial 

action plan; and (5) recordkeeping. The 

proposal would describe, in greater 

detail, the requirements for each 

element of the reasonable testing 

program. 

We received many comments on 

proposed subpart B. The comments 

addressed issues regarding the proposed 

provisions of a reasonable testing 

program on topics such as: product 

specifications, certification tests, 

samples for certification testing, 

production testing, remedial action, and 

recordkeeping. The commenters raised 

many concerns about the cost and 

burden of the proposal as well as 

practical issues, which illustrates the 

difficulty of drafting a regulation that 

can apply to many different types of 

products and manufacturing processes, 

yet still provide sufficient guidance to 

enable manufacturers to implement the 

requirements of a reasonable testing 

program effectively. Consequently, we 

are deferring action with respect to 

finalizing subpart B. We will reserve 

subpart B in the final rule and, except 

as stated otherwise in this preamble, 

continue evaluating the issues raised in 

the comments regarding a reasonable 

testing program. We note, however, that 

our deferral of action does not remove 

the responsibility of manufacturers, 

under section 14(a)(1) of the CPSA to 

certify based on tests of their products 

or based on reasonable testing programs 

that their products comply with all 

rules, bans, standards, or regulations 

applicable to such products. 

D. Proposed Subpart C—Certification of 

Children’s Products 

Proposed subpart C would contain the 

requirements for the certification of 

children’s products. The proposed 

subpart C would consist of seven 

sections and would implement most 

requirements in section 14(i)(2)(B) of the 

CPSA. 

1. General Comments 

Several commenters raised issues 

with respect to proposed subpart C 

generally, or on general concepts, such 

as testing. 

(Comment 14)—One commenter 

argued that the terms ‘‘reasonable 

assurance’’ and ‘‘sufficient number of 

samples’’ are likely to result in widely 

disparate interpretations. The 

commenter urged that ‘‘reasonable 

assurance’’ should be defined as a 

statistically significant number with a 

confidence level of 95 percent, based on 

testing enough samples to provide 

statistical validity. The commenter said 

that setting a specific confidence limit 

would enable us to enforce this section 

by avoiding subjectivity and by creating 

uniformity and consistency among 

manufacturers and conformity 

assessment bodies. 

The commenter noted that 

‘‘upstream’’ controls (i.e., processes, 

inspections, and tests conducted prior 

to or during product assembly intended 

to assure product quality), product risk 

assessments, and design analyses are 

reasonable tools for manufacturers to 

use but currently are not rigorous or 

specific enough to ensure 

‘‘downstream’’ compliance. Until they 

are, compliance must be determined by 

final product testing, the commenter 

asserted. 

(Response 14)—We decline to adopt 

the suggestion to set a 95 percent 

confidence level based on testing 

enough samples to provide statistical 

validity. Many manufacturing processes, 

such as those using continuous flow 

processes, are ill-suited to use a 

sampling technique for quality control 

purposes. In addition, for small-volume 

manufacturers, the number of samples 

required to achieve 95 percent 

confidence could be excessive, even to 

the point of requiring all of the products 

manufactured to be tested. 

Because the final rule’s testing 

requirements apply to a wide variety of 

children’s products, as well as to 

manufacturers of various sizes and 

different manufacturing processes, the 

rule must be flexible enough to allow 

the manufacturer to determine the best 

way to comply with the rule’s 

requirements. We are aware of 

numerous ‘‘upstream’’ quality assurance 

tools and processes that are widely used 

to ensure high levels of product 

performance. For example, techniques 

such as component part testing are 

particularly well-suited for determining 

compliance with the lead content limits 

for accessible parts on children’s 

products. Numerous international 

standards address quality control and 

assurance processes applied ‘‘upstream’’ 

in the product production process and 

can be used to extend the maximum 

periodic testing interval. Thus, we 

disagree with the commenter that none 

of these quality assurance tools and 

processes is rigorous or specific enough 

to ensure compliance. 

(Comment 15)—One commenter 

recommended a system of product risk 

assessment that would tailor the third 

party certification schedule for lowvolume firms, as follows: 

Children’s products: High-risk children’s 

products would require third party 

certification annually. Low-risk children’s 

products would require third party 

certification every three years. 

The commenter said that any test 

failure automatically would move the 

product into the next most stringent 

category. This system would focus the 

inspection of products on products that 

are the most dangerous to public safety. 

The commenter stated that an 

unintended consequence of this strategy 

would be to reward firms that make the 

safest products. 

(Response 15)—The commenter 

appears to be applying the proposed 

low-volume exception to periodic 

testing (stated in proposed § 1107.21(d)) 

to certification testing. The low-volume 

exception did not apply to certification 

testing. There is no schedule for any 

manufacturer for when a product is 

subject to certification testing, 

regardless of production volume. 

Instead, periodic testing is required for 

children’s products to ensure continued 

compliance with a high degree of 

assurance. 

Section 14(a)(2) of the CPSA requires 

certification testing for children’s 

products before they may be imported 

for consumption or warehousing or 

distributed in commerce. This initial 

testing of children’s products does not 

depend on product risk. Continuing 

compliance is demonstrated through 

periodic testing for children’s products, 

which specifies a maximum testing 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69491 

interval, based on the implementation of 

a periodic testing plan by the 

manufacturer. The final rule allows a 

manufacturer to consider risk to the 

extent it permits consideration of ‘‘the 

potential for serious injury or death 

resulting from a noncompliant product’’ 

as a factor in determining the 

appropriate periodic testing interval 

under a periodic testing plan. 

Regarding the commenter’s suggestion 

of devising a system of categorizing all 

children’s and non-children’s products 

subject to an applicable rule into risk 

categories, such a system would require 

a separate rulemaking effort and is 

beyond the scope of this rule. 

(Comment 16)—One commenter 

noted that the proposed rule did not use 

recognized industry terminology 

consistently. The commenter noted that 

the proposed rule relies on the terms 

‘‘test’’ or ‘‘testing,’’ as if all consumer 

product safety requirements could be 

evaluated by performing tests to ensure 

ongoing compliance. The commenter 

noted that, while full product testing is 

appropriate in some cases, current 

consumer product safety regulations 

imply or specify evaluation activities, 

not considered to be actual testing (e.g., 

inspections, reviews, audits), may be 

appropriate. 

The commenter noted that it 

recommended previously that we refer 

to Annex A of ISO/IEC 17000, 

Conformity assessment—Vocabulary 

and general principles, which provides 

a general description of the functional 

approach to activities that constitute 

conformity assessment, to address the 

question of the interpretation of the use 

of the terms ‘‘test’’ or ‘‘testing.’’ 

(Response 16)—The word ‘‘test’’ was 

chosen because of its use in section 

14(a) of the CPSA. ‘‘Certification tests’’ 

are tests on samples of the product that 

are identical in all material respects to 

the finished product. Section 14(i) 

(2)(B)(i) of the CPSA states that 

children’s products are subject to testing 

periodically and after a material change. 

The words ‘‘test’’ and ‘‘testing’’ are 

used throughout the final rule to mean 

a process used to determine whether a 

product is compliant with the 

applicable product safety rules. The 

process is geared to the particular 

product and specific safety rule. As 

such, testing may include inspection of 

labels and manuals, audits, and 

measurements to determine compliance 

with the applicable product safety rules. 

We believe that the definition of ‘‘test’’ 

and ‘‘testing’’ are clear. 

(Comment 17)—One commenter 

noted that we are not allowing the use 

of existing federally registered 

certification marks of third party 

conformity assessment bodies as an 

acceptable substitute for a certificate of 

conformity. The commenter added that 

introducing the new certificate of 

conformity will cause immediate 

confusion in the marketplace. The 

commenter suggested that we should 

have to justify, through a 

comprehensive and independent study, 

why we are departing from the existing 

system and why our proposed system 

would be better and more reliable. 

Another commenter stated that we 

should recognize certification marks 

issued by established third party 

certification programs as a substitute for 

the certificates of conformity described 

in the proposed rule when the product 

has been certified as compliant with 

associated product standards through a 

program that reflects CPSA 

requirements by an ISO/IEC Guide 65- 

accredited certification body. 

(Response 17)—Certification marks 

are symbols that a manufacturer is 

authorized to affix to their product to 

indicate that the product has been 

certified by a certification body. Third 

party certification involves testing, 

declarations of conformance, factory 

inspections, and continuing 

surveillance activities. The certification 

body attests that the product complies 

with the specified product safety rules 

that were evaluated. 

A certification mark does not contain 

the information required on a certificate 

by section 14(g) of the CPSA and cannot 

be used as a substitute for a Children’s 

Product Certificate. Section 14(a)(2) of 

the CPSA requires manufacturers of a 

consumer product that is subject to an 

applicable children’s product safety rule 

to issue a certificate certifying 

conformance of the children’s product 

to the applicable children’s product 

safety rules. Section 14(a)(2) of the 

CPSA does not allow a party other than 

the manufacturer, importer, or private 

labeler to issue a Children’s Product 

Certificate. 

Since the CPSIA was enacted in 2008, 

we have not observed immediate 

confusion in the marketplace regarding 

certificates. As noted above, 

certification marks cannot be used as a 

substitute for certificates if there is 

confusion in the marketplace. Thus, 

because section 14(a) of the CPSA 

requires the manufacturer to issue a 

certificate of conformity, an 

independent study is not warranted. 

Furthermore, on August 12, 2011, the 

President signed into law H.R. 2715, 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires us 

to review the public comments and 

states that we may prescribe new or 

revised third party testing regulations if 

we determine that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

(Comment 18)—One commenter 

noted that a publisher of ordinary books 

may have varying titles and content, but 

all of the books are made of the same 

materials in the same manner. The 

commenter asserted that the differences 

between ordinary books are not material 

to compliance with the applicable rules. 

Accordingly, the commenter said that 

having accredited third party 

conformity assessment body testing for 

a finished book would constitute 

finished product testing for all other 

books (International Standard Book 

Numbers, or ISBNs) that do not 

materially differ from the tested book 

with respect to compliance with CPSC 

safety standards. The commenter said a 

publisher with a reasonable testing 

program and a product without material 

changes could rely on the component 

part certifications for all materials 

published within a 2-year period. 

(Response 18)—Section 14(i)(5)(A)(i) 

of the CPSA, as amended by H.R. 2715, 

excludes ordinary books and ordinary 

paper-based printed materials from the 

third party testing requirements in 

14(a)(2) of the CPSA. Additionally, the 

final rule reserves subpart B, which 

would pertain to a reasonable testing 

program for non-children’s products. 

Therefore, it is unnecessary for us to 

consider how third party testing results 

for a book might be extended to all other 

books. 

(Comment 19)—One commenter 

asserted that only good design and 

comprehensive design review by 

qualified individuals will improve the 

safety of products. Therefore, the 

commenter suggested that we require 

‘‘design hazard analysis’’ in the 

certification of children’s products 

section of the final rule. ‘‘Design hazard 

analysis,’’ according to the commenter, 

identifies potential safety hazards in a 

consumer product that result from the 

design of the product. It involves 

determinations made by skilled 

professionals including engineers, 

chemists, and biologists about the 

features of a product that might result in 


emcdonald on DSK5VPTVN1PROD with RULES3
69492 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

safety hazards. The commenter asserted 

that the CPSC has the legal authority to 

require design hazard analysis of 

consumer products. 

The commenter suggested the 

following changes: 

• In Subpart C, Certification of 

Children’s Products, insert a new 

subsection 1107.20(a), Children’s 

Product Certification. (Note: The 

commenter may have meant to create a 

new subsection (a) and renumber the 

remaining subsections accordingly.) The 

new subsection would state: 

Prior to submitting samples of a children’s 

product for testing by a third party 

conformity assessment body, manufacturers 

must conduct a design hazard analysis and 

produce a design appraisal of the product 

that identifies and characterizes the potential 

hazards associated with that consumer 

product that are related to the design of a 

product. The design appraisal should 

include, at a minimum, an engineering, 

chemical, and biological analysis of the 

product, as appropriate to the type of product 

and the materials contained in the product. 

• Insert in § 1107.26(c), Remedial 

Action, after ‘‘* * * children’s product 

safety rules’’: 

If the manufacturer knows or reasonably 

should know that the failure of the product 

is related to the product’s design, the 

manufacturer shall conduct a revised design 

hazard review and produce a new design 

appraisal. 

(Response 19)—We agree that 

designing safety into a children’s 

product is an important part of a 

comprehensive quality control program. 

We decline, however, the commenter’s 

suggestion to include in the final rule 

requirements mandating design hazard 

analyses for children’s products. The 

current rulemaking is intended to 

implement the testing and certification 

requirements of section 14(a) and 

section 14(i)(2)(B) of the CPSA. 

Requiring a design hazard analysis goes 

beyond the statutory requirements 

because such an analysis would 

consider factors other than the factors 

required to demonstrate compliance 

with the applicable product safety rules. 

This action would extend the final rule 

to address activities that would occur 

before a product is manufactured. 

Currently, given the range of products 

that are subject to section 14 of the 

CPSA, we have no practical means of 

identifying or evaluating individuals 

whose credentials and experience, 

under the commenter’s suggested 

changes, would render them qualified to 

conduct design hazard analyses on 

products. Although the final rule does 

not require manufacturers to conduct a 

design hazard analysis on their 

products, manufacturers are free to 

engage in such analyses when 

developing or manufacturing a product. 

Further, as explained the section on 

remedial action in part III.D.7. below, 

we have removed from the final rule, 

the requirement for a remedial action 

plan for children’s products. 

(Comment 20)—One commenter 

suggested that final testing and 

certification should defer to the 

Occupational Safety and Health 

Administration (OSHA)-designated 

Nationally Recognized Testing 

Laboratory (NRTL) certification program 

by determining that such products, as 

they are manufactured and distributed 

for consumer use, are per se compliant 

with the proposed testing and 

certification rules. The commenter said 

we would still maintain our authority to 

recall products, seek civil penalties, and 

other remedies available to the 

Commission, if violations are found. 

(Response 20)—Pursuant to section 

14(a)(3)(C) of the CPSA, we have chosen 

to designate accrediting bodies that are 

full-member signatories to the 

International Laboratory Accreditation 

Cooperation—Mutual Recognition 

Arrangement (ILAC–MRA) to conduct 

third party testing. Given that children’s 

products intended for the U.S. market 

are manufactured in nations throughout 

the world, we decided to avoid 

designating accreditation programs or 

entities that are recognized only in a 

specific region, nation, or locality. The 

reasons for this are: (1) To keep the 

program as simple as possible for use by 

manufacturers, private labelers, 

importers, testing laboratories, and other 

interested parties; (2) to establish 

uniform requirements regardless of 

location; (3) to establish a program that 

is manageable within agency resources; 

and (4) to maintain a degree of 

consistency in the procedures used by 

the designated accrediting bodies. 

Moreover, the commenter appears to 

misstate testing requirements. Consumer 

products are not tested for whether they 

are compliant with the testing and 

certification rules (i.e., parts 1107 and 

1109), rather, consumer products are 

tested for compliance with the 

applicable rules, bans, standards, and 

regulations which the CPSC enforces. 

Moreover, section 14(i)(2)(B)(i) of the 

CPSA requires such testing periodically 

and when there has been a material 

change. Therefore, continued testing is 

required by the statute and ‘‘per se 

conformance’’ with the applicable 

product safety rules is not allowed. 

Additionally, section 14(a) of the CPSA 

requires manufacturers (including 

importers) to certify that their products 

comply with the applicable product 

safety rules. This responsibility cannot 

be delegated to another party, such as a 

certification body. 

The qualifications of testing 

laboratories performing certification 

tests are outside the scope of this final 

rule. Such qualifications are addressed 

in the various notices of requirements 

that we have published pursuant to 

section 14(a)(3) of the CPSA. 

Finally, we acknowledge that the 

recently–enacted H.R. 2715 requires us 

to seek public comment on 

‘‘opportunities to reduce the cost of 

third part testing requirements 

consistent with assuring compliance 

with any applicable consumer product 

safety rule, ban, standard, or 

regulation.’’ One topic which H.R. 2715 

requires us to address pertains to ‘‘the 

extent to which evidence of conformity 

with other national or international 

governmental standards may provide 

assurance of conformity to consumer 

product safety rules, bans, standards, or 

regulations applicable under [the 

Consumer Product Safety Act].’’ 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

inviting public comment on the issues 

identified in H.R. 2715, so the 

commenter’s argument would be more 

appropriately raised and addressed in 

that proceeding. We note, however, that 

very few products covered under the 

OSHA–designated Nationally 

Recognized Testing Laboratory 

certification program would be 

children’s products for which third 

party testing would be required. 

Moreover, those products that are 

subject to the OSHA certification 

program would likely be covered by 

CPSC regulations, if at all, for which the 

only requirement is a General 

Conformity Certificate based on a 

reasonable testing program. OSHA 

certification testing may be a sufficient 

basis for such certifications depending 

on the product and the type of testing 

involved. Given that CPSC does not 

have jurisdiction over products when 

the risks of injury associated with the 

consumer product could be eliminated 

or reduced to a sufficient extent by the 

actions of OSHA, there may be very 

little overlap between a particular 

product’s results under OSHA’s testing 

program and any CPSC required testing. 

(Comment 21)—One commenter 

suggested an evidenced-based approach 

to certification, based on historical 

performance and risk for the product 

type and manufacturing process. The 

commenter suggested that an importer/ 

retailer may implement a program 

requiring: 

• Sample testing using materially 

identical components to be completed 

before production begins; 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69493 

• Certification from samples selected 

during the start of production; and 

• Periodic testing as the item remains 

in production. 

At each of these stages, a 

representative set of samples would be 

pulled to cover all tests related to the 

applicable rules, bans, standards, and 

regulations. 

The commenter suggested the 

following example: 

For a child’s solid rubber ball, more than 

10,000 finished products that are materially 

identical could be made in less than one 

manufacturing shift. In this scenario, it 

would be appropriate to select samples when 

material changes occur and or meet 

historically defined frequency intervals in 

order to maintain and validate that products 

meet all rules, bans, standards, and 

regulations. 

The commenter would like the CPSC 

to acknowledge that for children’s 

products, samples selected from a lot of 

finished product over 10,000 pieces, but 

produced in a short time period, may be 

used to satisfy certification testing and 

periodic testing requirements. 

(Response 21)—Section 14(a)(2) of the 

CPSA requires a manufacturer or 

importer of a children’s product subject 

to a children’s product safety rule to 

submit sufficient samples of the 

children’s product, or samples that are 

identical in all material respects to the 

product, to a third party conformity 

assessment body whose accreditation 

has been accepted by us to be tested for 

compliance with the applicable 

children’s product safety rules. This 

requirement is also set forth in 

§ 1107.20(a) of the final rule. Thus, the 

commenter’s first two suggestions—to 

choose samples for testing using 

materially identical components, and to 

select samples during the start of 

production, would likely fulfill the 

statutory requirement to submit samples 

that are identical in all material respects 

to the product, for purposes of 

certification testing. 

Section 14(i)(2)(B)(i) of the CPSA 

requires, in part, that we establish 

protocols and standards to ensure that a 

certified children’s product is tested for 

compliance periodically. Section 

1107.21 of the final rule details periodic 

testing requirements for children’s 

products. Accordingly, the commenter’s 

suggestion regarding periodic testing is 

required by the statute, and our 

expectation with regard to periodic 

testing is articulated in the final rule. 

Regarding the commenter’s suggestion 

regarding short-period production runs 

of children’s products, the same 

samples may be used for certification 

and periodic tests. If a testing plan is 

designed and implemented to meet the 

requirements of §§ 1107.20 and 1107.21, 

then the requirements to demonstrate 

the product’s ability to meet all 

applicable children’s product safety 

rules and ensure that continuing 

production is compliant may be met in 

this manner. If the manufacturer has a 

high degree of assurance of the 

children’s product compliance, and the 

production run does not extend beyond 

the maximum periodic testing interval, 

then no third party periodic tests may 

be required. However, no children’s 

product may enter into commerce 

without a Children’s Product Certificate 

based on passing test results from a 

CPSC-accepted third party conformity 

assessment body certification. 

(Comment 22)—Some commenters 

stated that the safety performance of a 

finished product may not be able to be 

based solely on the compliance of its 

component parts. The commenters 

asserted that some requirements can be 

evaluated only with finished product 

samples. The commenters asked us to 

clarify which products and which 

regulations would be amenable to 

component part testing. One commenter 

suggested that electrical safety standards 

and regulations (i.e., fire and shock 

hazard testing) should not be allowed to 

rely solely on component part testing. 

(Response 22)—The commenters are 

correct that some requirements can be 

evaluated only with finished product 

samples, and not with tests on 

component parts. However, both this 

final rule and the final rule on 

Conditions and Requirements for 

Relying on Component Part Testing or 

Certification, or Another Party’s 

Finished Product Testing or 

Certification, to Meet Requirements in 

Sections 14(a) and 14(i) of the 

Consumer Product Safety Act (16 CFR 

part 1109) contain restrictions on the 

use of component part testing. For 

example, § 1107.20(c) of the final rule 

states that except where otherwise 

specified by a children’s product safety 

rule, component part testing pursuant to 

16 CFR part 1109 may be used to 

support the certification testing 

requirements of this section. The final 

rule for 16 CFR part 1109 states that if 

a certifier has doubts about whether 

component part testing is sufficient to 

demonstrate compliance with all the 

applicable rules, bans, standards, or 

regulations, those doubts should be 

resolved in favor of testing the finished 

product. 

Therefore, the commenters’ concerns 

are addressed by the requirements of the 

two rules. 

(Comment 23)—One commenter 

expressed concern about the final rule’s 

effect on laboratory testing capacity and 

suggested removing references to 

statistical sampling and the use of 

ANSI/ASQ Z1.4, Sampling Procedures 

and Tables for Inspection by Attributes 

and Z1.9, Sampling Procedures and 

Tables for Inspection by Variables for 

Percent Nonconforming, for determining 

the number of samples required for 

certification testing, production testing, 

and periodic testing. The commenter 

said the frequency of testing and the 

number of samples tested should be set 

or determined by retailers and 

manufacturers to assure compliance 

with all applicable rules, bans, 

standards and regulations. The 

commenter stated that referencing the 

use of statistical sampling, confidence 

levels, and ANSI/ASQ Z1.4 & Z1.9 

implies a very significant increase in the 

number of samples required for product 

testing. 

(Response 23)—For manufacturers or 

importers using tests on samples of a 

product to ensure continued compliance 

to the applicable product safety rules, 

the rule permits manufacturers or 

importers to determine the frequency of 

testing and the number of samples 

tested to ensure compliance. Retailers 

only have testing or certification 

obligations if they are importers. The 

commenter did not explain how 

removing references to quality 

management and control standards and 

sampling procedures, which are not 

required, but may be used voluntarily 

by certifiers, would address the issue of 

third party conformity assessment body 

testing capacity. However, the proposed 

rule’s reference to ASNI/ASQ Z1.4 and 

Z1.9 had the potential to mislead 

manufacturers because it would use the 

term ‘‘Acceptable Quality Level (AQL).’’ 

An AQL can be interpreted as an 

acceptable percentage of nonconforming 

products, which is not appropriate 

when applied to the case of compliance 

of products to health and safety 

standards. Therefore, we have deleted 

references to these standards in the final 

rule. 

(Comment 24)—One commenter 

noted that the Labeling of Hazardous 

Art Materials Act (LHAMA) established 

the requirements for the labeling of art 

materials in ASTM D–4236, which is 

referenced in 16 CFR 1500.14(b)(8). The 

commenter asked that we: (1) Clarify the 

meaning of this provision with respect 

to the certification of art materials under 

section 14 of the CPSA; and (2) state 

whether LHAMA is a labeling rule 

under the Federal Hazardous 

Substances Act (FHSA) that would not 

require testing and certification to 

LHAMA under the CPSA. The 

commenter further proposed the use of 

existing facilities and procedures 


emcdonald on DSK5VPTVN1PROD with RULES3
69494 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

allowed for LHAMA to certify 

compliance with the CPSIA. 

(Response 24)—LHAMA requires that 

the manufacturer, importer, or 

repackager of art materials have a 

product’s formulation reviewed by a 

toxicologist for its potential to cause 

chronic adverse health effects. A 

conformance statement on the product 

is used to certify that the product has 

been so reviewed. However, section 101 

of the CPSIA introduces additional 

testing requirements for lead in 

children’s products beyond what is 

required under LHAMA, so certification 

of art materials under LHAMA is not 

necessarily equivalent to testing for lead 

pursuant to section 101 of the CPSIA 

and section 14 of the CPSA. 

Regarding whether LHAMA is a 

labeling requirement under the FHSA 

that would not require testing and 

certification, we note that LHAMA does 

not contain a performance standard 

similar to those in consumer product 

safety rules but rather, requires labeling 

in the form of a conformance statement 

that the product formulation has been 

reviewed by a toxicologist. The 

requirements of LHAMA are similar to 

the labeling requirements of the FHSA, 

of which LHAMA is a part. Therefore, 

third party testing for conformance to 

LHAMA is not required. Art materials 

designed or intended primarily for 

children 12 years of age or younger 

would have to be tested by a CPSCaccepted third party conformity 

assessment body to demonstrate 

compliance with the lead content limits, 

but they would not require third party 

testing and certification to the LHAMA 

requirements. 

Regarding using facilities for LHAMA 

to certify to CPSIA requirements, 

section 14(f)(2)(C) of the CPSA states 

that a certifying organization, as defined 

in appendix A to 16 CFR 1500.14(b)(8), 

‘‘meets the requirements’’ for 

consideration as a third party 

conformity assessment body ‘‘with 

respect to the certification of art 

materials and art products required 

under this section or by regulations 

prescribed under the Federal Hazardous 

Substances Act.’’ Thus, an organization 

that is a certifying organization with 

respect to LHAMA is a third party 

conformity assessment body and may 

test children’s art materials and art 

products for compliance with LHAMA. 

Thus, insofar as certifying organizations 

and LHAMA are concerned, no changes 

to the proposed rule are necessary. 

Accreditation requirements for testing 

for compliance with the CPSIA, other 

than LHAMA, are beyond the scope of 

this rulemaking and may be addressed 

in a separate rulemaking. 

(Comment 25)—Multiple commenters 

noted that manufacturers have 

established first party testing 

laboratories that are accredited to ISO/ 

IEC 17025:2005(E) (more commonly 

known as ISO/IEC 17025:2005 and how 

it will be referred to in the preamble), 

General requirements for the 

competence of testing and calibration 

laboratories. The commenters suggested 

that for manufacturers with such 

laboratories, we should allow test 

results from those facilities to be used 

for children’s product certification 

purposes. Many commenters suggested 

that one half of the testing for 

certification should be allowed at inhouse testing facilities; others 

recommended that the number of 

samples sent to third party conformity 

assessment bodies for certification 

purposes be reduced ‘‘to a minimum.’’ 

Some commenters stated that we should 

recognize internal laboratories as a way 

to reduce dependence on third party 

conformity assessment bodies. The 

reasons for the suggestions include: A 

desire to reduce testing costs, to 

encourage other manufacturers to 

develop their own internal testing 

facilities, and to promote continuous 

product improvements. 

(Response 25)—Section 14(a)(2) of the 

CPSA explicitly requires that testing of 

children’s products be conducted by a 

third party conformity assessment body 

as a condition of certification. Further, 

third party conformity assessment 

bodies must have a CPSC-accepted 

accreditation for the scope of the testing 

undertaken in support of product 

certification. Unless the manufacturer’s 

laboratory is a CPSC-accepted firewalled 

conformity assessment body, first party 

testing facilities, regardless of ISO/IEC 

17025:2005 accreditation status, cannot 

be used for children’s product 

certification purposes. 

We note that, in response to these 

comments and concerns raised about 

cost, § 1107.21(d) of the final rule allows 

manufacturers using in-house testing 

laboratories accredited to ISO/IEC 

17025:2005 to ensure continued 

compliance, to conduct periodic testing 

at a maximum testing interval of three 

years. 

We further note that on August 12, 

2011, the President signed into law H.R. 

2715, which amended the CPSIA in 

several respects. One provision in H.R. 

2715 requires us to seek public 

comment on opportunities to reduce the 

cost of third party testing requirements, 

consistent with assuring compliance 

with any applicable consumer product 

safety rule, ban, standard, or regulation. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires us 

to review the public comments and 

states that we may prescribe new or 

revised third party testing regulations if 

we determine that such regulations will 

reduce third party testing costs, 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

(Comment 26)—One commenter 

noted that carpets and rugs currently 

require flammability testing in 

accordance with 16 CFR parts 1630 and 

1631 and suggested that there is no need 

for an additional flammability testing 

procedure for youth carpets and rugs. 

(Response 26)—Section 14(a)(2) of the 

CPSA requires third party conformity 

assessment body testing of children’s 

products (or samples that are identical 

in all material respects) subject to a 

children’s product safety rule for initial 

certification purposes. Further, section 

14(f)(1) of the CPSA defines a 

‘‘children’s product safety rule’’ as a 

consumer product safety rule enforced 

by the Commission. Section 3(a)(2) of 

the CPSA defines a ‘‘children’s product’’ 

as a consumer product designed or 

intended primarily for children 12 years 

of age or younger. Thus, because youth 

carpets and rugs are children’s products 

and are subject to the consumer product 

safety rules 16 CFR parts 1630 and 1631, 

third party testing is required. 

For these reasons, initial certification 

testing for youth carpets and rugs must 

be performed by a CPSC-accepted third 

party conformity assessment body 

whose accreditation includes the scope 

of the tests. Second, children’s products 

are subject to requirements for periodic 

testing, material changes, undue 

influence, and recordkeeping in subpart 

C of the final rule. The test methods in 

16 CFR parts 1630 and 1631 are still 

applicable. 

(Comment 27)—One commenter 

stated that the statutory requirements 

for certificates in section 14(a) of the 

CPSA impose strict and detailed 

requirements for the contents and 

availability of certificates of conformity 

that document compliance of a 

children’s product as demonstrated 

through test results. A certificate based 

on accredited third party conformity 

assessment body testing must be issued 

by the manufacturer and private labeler 

of any children’s product that is subject 

to a CPSC rule, and it must comply not 

only with the requirements of section 

14(g) of CPSA, but also with the 

requirements of a finished product 

certifier’s reliance on component 

materials testing certification. Thus, a 

finished product certifier could rely on 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69495 

a test report showing passing test results 

for one or more component materials 

used in the product, based upon 

accredited third party conformity 

assessment body testing conducted by 

another person. 

The commenter stated that including 

this information in the certificate 

accompanying the finished children’s 

product would create logistical 

nightmares for the manufacturers and 

private labelers of children’s products. 

The commenter did not object to the 

‘‘recordkeeping’’ requirements in 

proposed § 1107.26; however, the 

commenter urged us to note that 

compliance with these requirements 

should make it unnecessary for the 

manufacturer or private labeler of the 

finished children’s product, to ensure 

that every certificate required under 

section 14 of the CPSA accompanies the 

product or shipment of products, is 

furnished to each distributor or retailer 

of the product. 

The commenter also urged us to adopt 

certificate requirements that reflect the 

key concept in the tracking label 

provisions, which require that the 

manufacturer (as well as the ‘‘ultimate 

purchaser’’) of the finished children’s 

product be able to ‘‘ascertain’’ certain 

information similar to what is required 

for certificates of conformity. The 

commenter suggested that certificates, 

like ‘‘tracking labels,’’ for children’s 

products under section 103 of CPSIA, 

could be mandated to use codes or other 

means to point all interested parties to 

a source where such information readily 

can be found. This code could be 

contact information, where the 

manufacturer or private labeler could 

include an Internet URL for the 

manufacturer’s Web site, where the 

information could be accessed. 

(Response 27)—Section 14(g)(1) of the 

CPSA and 16 CFR 1110.11 require 

specific information on each certificate. 

In addition, section 14(g)(3) of the CPSA 

states that the required certificate shall 

accompany the applicable product or 

shipment of products covered by the 

same certificate and a copy of the 

certificate shall be furnished to each 

distributor or retailer of the product. 

However, 16 CFR 1110.9 allows a 

manufacturer to file certificates 

electronically by providing an Internet 

URL for the manufacturer’s Web site, 

where the information could be 

accessed, as the commenter suggested. 

We note that the listing of component 

parts or component part test results does 

not have to be included on the finished 

product certificate. 

(Comment 28)—Multiple commenters 

mentioned the high costs associated 

with third party testing and noted that 

the proposed rule under-recognizes the 

in-house quality assurance and testing 

capabilities of manufacturers. 

(Response 28)—We are aware of many 

effective quality assurance techniques 

that are widely used to control quality 

in product manufacturing. However, 

section 14(a)(2) of the CPSA requires 

third party conformity assessment body 

testing of children’s products for initial 

certification. Unless the manufacturer’s 

in-house testing facility is a CPSCaccepted firewalled conformity 

assessment body, data from those 

facilities cannot be used for children’s 

product certification purposes. No 

exclusion is included in the statute for 

first party certification or periodic 

testing of children’s products based on 

the costs of testing. 

In response to these comments, and in 

response to concerns about the cost of 

third party testing, § 1107.21(d) of the 

final rule allows manufacturers who are 

implementing a production testing plan 

to ensure the compliance of continuing 

production, to conduct third party 

periodic testing at a maximum testing 

interval of two years. Further, the final 

rule allows manufacturers using inhouse testing laboratories accredited to 

ISO/IEC 17025:2005 to ensure 

continued compliance by conducting 

third party periodic testing at a 

maximum testing interval of three years. 

We believe this balances the desire for 

unbiased objective test results with the 

cost concerns expressed in the 

comments. 

Additionally, on August 12, 2011, the 

President signed into law H.R. 2715, 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires the CPSC to seek public 

comment on opportunities to reduce the 

cost of third party testing requirements 

consistent with assuring compliance 

with any applicable consumer product 

safety rule, ban, standard, or regulation. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires us 

to review the public comments and 

states that we may prescribe new or 

revised third party testing regulations if 

we determine that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

2. Proposed § 1107.20—General 

Requirements 

a. The Number of Samples 

Proposed § 1107.20(a) would require 

manufacturers to submit a sufficient 

number of samples of a children’s 

product, or samples that are identical in 

all material respects to the children’s 

product, to a third party conformity 

assessment body for testing to support 

certification. The proposal would 

require that the number of samples 

selected provide a high degree of 

assurance that the tests conducted for 

certification purposes accurately 

demonstrate the ability of the children’s 

product to meet all applicable children’s 

product safety rules. 

(Comment 29)—Two commenters 

wanted more detail on what is meant by 

‘‘a sufficient number of samples.’’ The 

commenters expressed concern that, if 

the number is left to conformity 

assessment bodies, there will be too 

much variability among conformity 

assessment bodies about what is a 

sufficient number. 

(Response 29)—A ‘‘sufficient number 

of samples’’ are the number of samples 

necessary to give the manufacturer or 

importer a high degree of assurance of 

the product’s compliance with the 

applicable rules when tested. Because a 

high degree of assurance is based upon 

the manufacturer’s or importer’s 

knowledge of the product and its 

manufacture, a sufficient number of 

samples will vary based on those 

factors. For example, for products with 

highly consistent part-to-part 

manufacturing processes (e.g., die 

casting), fewer samples may be 

necessary to give the manufacturer/ 

importer a high degree of assurance of 

compliance. For processes with more 

variability (such as hand assembly), it is 

likely that more samples will be 

necessary to achieve the same high 

degree of assurance. 

The commenters also may have 

misunderstood the role of conformity 

assessment bodies in the testing and 

certification requirements of the rule. 

The conformity assessment body does 

not specify the number of samples to be 

tested. The manufacturer or importer 

specifies to the conformity assessment 

body the number of samples to be 

tested. 

Finally, on our own initiative, we 

revised the second sentence to say that 

the number of samples selected must 

‘‘be sufficient to’’ provide a high degree 

of assurance. We added this language to 

be consistent with the requirement to 

‘‘submit a sufficient number of samples’’ 

language in the first sentence of the 

section. This change is also consistent 

with section 14(a)(2)(A) of the CPSA, 

which requires a manufacturer to 

‘‘submit sufficient samples of the 

children’s product’’ for testing. 

(Comment 30)—One commenter 

stated that the language covering 


emcdonald on DSK5VPTVN1PROD with RULES3
69496 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

samples needs to be clarified. The 

commenter stated that the proposal 

would require testing with a ‘‘sufficient 

number of samples’’ to provide a ‘‘high 

degree of assurance’’ (for minimum 

certification testing), while maintaining 

that the sampling does not have to meet 

minimum standards of statistical 

confidence. However, the commenter 

noted that the comments accompanying 

the proposed rule recognize that ‘‘there 

may be difficulty in applying statistical 

methods to all manufacturing 

processes.’’ 

The commenter further stated that if 

testing a ‘‘sufficient number of samples 

to provide a high degree of assurance’’ 

is required when applying a reasonable 

testing program to children’s products, 

then we should provide guidance on 

alternatives that certifiers may use to 

fulfill the duty to justify their plan, were 

they to choose anything less than a 

random statistical sample. The 

commenter noted that historically, we 

have relied on a sample of 12 or fewer 

units, without regard to the size of the 

production run and that certain 

statistical models used by auditors 

impose a maximum sample of 25 units, 

no matter the size of the cohort from 

which the samples are selected. 

Based on these points, the commenter 

recommended that we delete the 

requirement to test a ‘‘sufficient number 

of samples to provide a high degree of 

assurance’’ under a reasonable testing 

program. The commenter said that the 

premise of a ‘‘reasonable testing 

program’’—in order to differentiate it 

from the mandatory periodic testing 

required for children’s products not 

relying upon a reasonable testing 

program—must be that, for some 

specific products, testing will not be the 

basis for certifying to the applicable 

rule. The commenter stated that we 

appropriately acknowledged the 

implications of differences between 

product categories and industries 

attempting to develop programs when, 

in the preamble to the proposed rule, we 

observed: ‘‘A manufacturer may develop 

the scope and details of each element of 

a reasonable testing program based on 

knowledge and expertise regarding the 

product and its manufacturing 

processes’’ (75 FR at 28345). The 

commenter stated that this discretion 

also must extend to the sample selection 

method of test programs, provided that 

all population elements have a chance 

of selection and due care is exercised to 

avoid selection bias through 

documented procedures. 

The commenter also stated that we 

should suggest separate regulations for 

specific products that may warrant 

prescribed methods, as has been done 

with bicycle helmets. The commenter 

expressed the belief that this is the kind 

of evidence-based decision making we 

envisioned in rejecting a single 

definition of ‘‘high degree of assurance’’ 

within a reasonable testing program for 

non-children’s products. 

(Response 30)—Although subpart B, 

describing a reasonable testing program, 

has been reserved in the final rule, the 

concept of certification testing and 

testing a sufficient number of samples to 

provide a high degree of assurance of 

compliance with applicable rules, bans, 

standards, and regulations remains in 

the final rule with regard to children’s 

products in § 1107.20(a). We disagree 

with the commenter’s assertion that 

‘‘testing with a sufficient number of 

samples to provide a high degree of 

assurance’’ requires the testing method 

to meet minimum standards of 

statistical confidence. In the preamble to 

the proposed rule (75 FR at 28344), the 

discussion of a high degree of assurance 

intentionally avoided choosing a 

statistically based definition for the 

term. Therefore, the certifier is allowed 

to choose other means, using its 

knowledge of the product and how it is 

manufactured, to determine what would 

be a sufficient number of samples. A 

certifier may use statistical methods, but 

the determination of a sufficient number 

of samples to achieve a high degree of 

assurance is not required to be 

statistically based. 

We decline to provide guidance on 

alternatives that certifiers may use to 

fulfill the duty to justify their plan if 

they were to choose anything other than 

a random statistical sample. With the 

wide variety of children’s products, 

manufacturers, and manufacturing 

processes that will be subject to the final 

rule, it would be impractical to attempt 

to provide guidance applicable to all or 

to attempt to provide individualized 

guidance for some or all products, as 

requested by the commenter. Because 

the certifier typically possesses greater 

knowledge of the product and how it is 

made than other parties possess, the 

certifier is in the best position to 

determine how to achieve a high degree 

of assurance that its products are 

compliant with all the applicable 

children’s product safety rules. 

Regarding the commenter’s 

observation of the CPSC’s use of 12 or 

fewer samples, those samples were not 

used for children’s product certification 

purposes. Thus, tests run by CPSC staff 

are not germane to the discussion of 

product certification. Depending upon 

the manufacturer’s knowledge of a 

children’s product and its manufacture, 

a sufficient number of samples to 

provide a high degree of assurance of 

compliance with the applicable 

children’s product safety rules may be 

greater, or fewer, than 12. 

The commenter may be 

misunderstanding the rule as it relates 

to random samples. In proposed 

§ 1107.22, the testing of random samples 

was required only during periodic tests 

of children’s products subject to an 

applicable children’s product safety 

rule. Pursuant to H.R. 2715, the testing 

of ‘‘random samples’’ to ensure 

continued compliance has been 

replaced with testing of ‘‘representative 

samples’’ to ensure continued 

compliance. Given the change in the 

statute, we have decided to remove 

§ 1107.22 in the final rule. Regardless, 

certification testing in the proposed rule 

never required the selection of random 

samples for children’s products. 

For children’s products, section 

14(a)(2)(A) of the CPSA requires that 

every manufacturer or private labeler of 

a children’s product: 

Submit sufficient samples of the children’s 

product, or samples that are identical in all 

material respects to the product, to a third 

party conformity assessment body accredited 

* * * to be tested for compliance with such 

children’s product safety rule. 

Therefore, the statute requires 

children’s products to be tested before 

they can be certified, and the statutory 

requirement for third party periodic 

testing applies. 

We agree that there are instances in 

which it may be preferable to specify a 

testing program in a particular 

regulation, and several of our existing 

regulations require such programs. 

Should a particular standard at some 

point necessitate consideration of such 

an approach, we will provide due 

consideration of how to specify, within 

the statutory framework that requires 

third party certification and third party 

periodic testing, such a particular 

testing program. 

(Comment 31)—One commenter 

expressed concern about the 

requirement to perform certification 

tests. The commenter said they did not 

believe that a requirement to test preproduction samples should be part of a 

reasonable testing program, adding that 

it may be impractical for seasonal items 

or short production runs. The 

commenter stated that preproduction 

samples cannot be tested because we 

will not accept the test results on 

samples as test results on the finished 

product. The commenter asked: if the 

preproduction samples fail and the 

retailer/importer has the product 

reworked by the manufacturer to correct 

any defects, and the production units 

pass tests to meet all applicable 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69497 

standards, then why should it matter if 

the samples failed, as long as the final 

product meets the requirements? The 

commenter expressed the belief that 

sample testing should be optional, not 

required. 

(Response 31)—Although subpart B, 

describing a reasonable testing program, 

has been reserved in the final rule, the 

concept of certification testing and 

testing a sufficient number of samples to 

provide a high degree of assurance of 

compliance with applicable rules, bans, 

standards, and regulations remains in 

the final rule with regard to children’s 

products in § 1107.20(a). Section 

1107.20(a) states that certification tests 

must be performed on samples that are 

identical in all material respects to the 

children’s product distributed in 

commerce. Thus, finished children’s 

product samples or preproduction 

samples are acceptable for certification 

test purposes if their performance for 

the test under consideration is the same 

as the finished product. 

The commenter did not explain why 

they believe that certification tests may 

be impractical for seasonal or short 

production run items. Thus, we cannot 

respond to the commenter’s concern. 

The final rule requires passing 

certification test results before a 

Children’s Product Certificate can be 

issued. 

With regard to the commenter’s 

concern regarding a test failure of 

preproduction samples, the commenter 

may have misunderstood the 

requirements of certification testing. 

The commenter described a 

circumstance in which a manufacturer 

tested samples for compliance to a 

regulation. Upon receiving a failing test 

result, the manufacturer addressed the 

causes of the failing test results and 

conducted new certification tests on 

samples of the ‘‘corrected’’ product and 

received passing test results. This 

describes an acceptable process for 

initial product certification. 

We disagree with the commenter’s 

suggestion that certification tests should 

be optional. Section 14(a)(2) of the 

CPSA expressly refers to testing as being 

the basis of a certification and does not 

make such testing optional. 

(Comment 32)—A commenter 

suggested that the final rule not require 

finished product/component part testing 

and should allow samples that are 

identical in all material respects to the 

finished product to be tested. The 

commenter added that testing on 

samples since the 1950s has not resulted 

in a recall for failing to comply with the 

applicable rule. Thus, requiring finished 

product/component testing would be 

extremely costly and burdensome and 

would not increase safety. The 

commenter would revise the rule to 

make it clear that component parts that 

are materially similar to the finished 

part can be used for certification testing. 

(Response 32)—We agree with the 

commenter regarding the testing of 

samples. Section 1107.20(a) states that 

samples must be identical in all material 

respects to the children’s product. 

We also agree with the commenter’s 

suggestion that we clarify the rule; 

therefore, we have revised § 1107.20(c) 

to state that component part testing may 

be used for certification of a finished 

product. 

(Comment 33)—One commenter 

expressed the belief that the 

manufacturer should determine the 

number of units to be tested, but added 

that they do not believe that statistical 

sampling is appropriate. 

(Response 33)—A manufacturer may 

use statistical or qualitative means to 

determine how many units of a product 

are needed for certification testing to 

give the manufacturer a high degree of 

assurance that the product complies 

with the applicable rules. The 

manufacturer is not required to use 

statistical methods, but they should be 

prepared to describe how their 

technique shows the product’s 

compliance. 

(Comment 34)—One commenter 

noted that products using ‘‘food grade’’ 

materials have supplier certificates 

stating that these materials meet the 

requirements of the Federal Food, Drug, 

and Cosmetic Act (FFDCA) and/or the 

packaging requirements for the 

Coalition of Northeastern Governors 

(CONEG). The commenter suggested 

supplementing these certificates with 

other analyses, as part of the 

certification (e.g., gas chromatography— 

mass spectrometry, GC–MS) and a 

reasonable testing program. The 

commenter said that such assurances 

also can be used, consistent with the 

Commission’s authority under section 3 

of the CPSIA, to reduce the burden of 

testing on manufacturers of consumer 

products. Because the proposed rule 

would acknowledge that children’s 

product manufacturers who implement 

a reasonable testing program have a 

reduced third party test burden from the 

standpoint of third party periodic 

testing, the commenter said that such 

compliance assurances can be 

incorporated into a program for 

children’s products as well. 

(Response 34)—Section 14(a)(2) of the 

CPSA requires third party conformity 

assessment body testing of children’s 

products as a condition of certification. 

Additionally, those third party 

conformity assessment bodies must 

have a CPSC-accepted accreditation for 

the scope of the testing undertaken in 

support of product certification. ‘‘Food 

grade’’ materials and CONEG 

requirements are not conducted by these 

laboratories and do not necessarily 

demonstrate compliance with the 

requirements of applicable children’s 

product safety rules or compliance with 

the third party testing requirement in 

section 14(a)(2) of the CPSA. 

Accordingly, we cannot adopt those 

certifications in lieu of the certification 

required under section 14(a)(2) of the 

CPSA. 

While manufacturer-supplied 

certificates stating that these materials 

meet FFDCA or CONEG requirements 

may not be used as the basis for a third 

party-supported product certification, 

they can be used as part of a production 

testing plan implemented to extend the 

maximum periodic testing interval from 

one year to two years if they are 

sufficient to demonstrate compliance 

with a children’s product safety rule 

such as the lead content limits. We note 

that some food additives are GRAS, or 

‘‘generally recognized as safe.’’ 

However, these designations might not 

be based on scientific analyses or 

testing. Instead, the GRAS status for a 

material might be based on longstanding 

acceptance or belief. 

Furthermore, on August 12, 2011, the 

President signed into law H.R. 2715, 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements, consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. H.R. 

2715 directs us to seek public comment 

on seven specific issues, including the 

extent to which the use of materials 

subject to regulations of another 

government agency that requires third 

party testing of those materials may 

provide sufficient assurance of 

conformity with an applicable consumer 

product safety rule, ban, standard, or 

regulation without further third party 

testing. Elsewhere in this issue of the 

Federal Register, we have published a 

notice seeking public comment on the 

issues in H.R. 2715. 

H.R. 2715 further requires us to 

review the public comments and states 

that we may prescribe new or revised 

third party testing regulations if we 

determine that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. Should new information 


emcdonald on DSK5VPTVN1PROD with RULES3
69498 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

become available, the Commission may 

revisit this issue in the future. 

b. The Interaction Between the 

Manufacturing Process and Samples 

Proposed § 1107.20(b) would state 

that, if the manufacturing process for a 

children’s product consistently creates 

parts that are uniform in composition 

and quality, a manufacturer may submit 

fewer samples to provide a high degree 

of assurance that the finished product 

complies with the applicable children’s 

product safety rules. If the 

manufacturing process for a children’s 

product results in variability in the 

composition or quality of children’s 

products, a manufacturer may need to 

submit more samples to provide a high 

degree of assurance that the finished 

product complies with the applicable 

children’s product safety rules. 

(Comment 35)—One commenter 

stated that phrases, such as ‘‘sufficient 

number of samples’’ and ‘‘variability in 

composition or quality,’’ can be 

confusing. The commenter said that 

regular internal monitoring and periodic 

testing should be able to provide 

sufficient data and information to 

support any assessment of product 

quality. 

(Response 35)—The commenter is 

correct that internal monitoring and 

testing can provide data to support the 

assessment of product quality. Because 

§ 1107.20 applies to both tightly and 

loosely controlled manufacturing 

processes, we emphasize in § 1107.20(b) 

of the final rule that the number of 

samples needed to give the certifier a 

high degree of assurance of the 

product’s compliance is affected by how 

well the product’s manufacturing 

process controls those variables 

associated with compliance. A sufficient 

number of samples would be the 

quantity of samples selected for 

certification testing that gives the 

certifier a high degree of assurance that 

the product complies with all the 

applicable children’s product safety 

rules. 

‘‘Variability in the composition or 

quality,’’ for purposes of § 1107.20, 

means unit-to-unit differences of a 

product that can affect its compliance 

with the applicable children’s product 

safety rules. 

We have finalized this paragraph 

without change. 

(Comment 36)—One commenter 

stated that regular internal monitoring 

and periodic testing should be able to 

provide sufficient data and information 

to support any assessment of product 

quality. The commenter noted that this 

procedure is commonly practiced by 

many manufacturers at present. 

(Response 36)—Section 1107.20(b) of 

the final rule states, in part, that if the 

manufacturing process for a children’s 

product consistently creates finished 

products that are uniform in 

composition and quality, a 

manufacturer may submit fewer samples 

to provide a high degree of assurance 

that the finished product complies with 

the applicable children’s product safety 

rules. We interpret the comment to 

assert that internal manufacturing 

controls and regular testing should 

obviate the need for numerous samples 

for product certification. The 

commenter is correct in that the 

manufacturer’s internal controls and 

testing can provide information to use 

in determining how many certification 

test samples would be required to give 

the certifier a high degree of assurance 

of the product’s compliance with the 

applicable rule. 

c. Component Part Testing 

Proposed § 1107.20(c) would state 

that, except where otherwise specified 

by a children’s product safety rule, a 

manufacturer may substitute component 

part testing for finished product testing 

pursuant to 16 CFR part 1109, if the 

component part, without the remainder 

of the finished product, is sufficient to 

determine compliance for the finished 

product. 

(Comment 37)—One commenter 

requested that we make an explicit 

statement about component testing 

indicating that certain components are 

exempt from testing and certification. 

The commenter was concerned that, 

without specific language, the final 

customer will not accept component 

testing if exempt parts are not tested. 

The commenter recommended revising 

proposed § 1107.20(c) as follows: 

(c) Except where otherwise specified by a 

children’s product safety rule, a 

manufacturer may substitute component part 

testing for complete product testing pursuant 

to 16 CFR [part] 1109 if the component part, 

without the remainder of the finished 

product, is sufficient to determine 

compliance for the entire product. 

Component part testing can be used to 

substantiate compliance for those children’s 

products where part of the product has been 

exempted from testing pursuant to Section 

1500.91. (Italics indicate proposed language.) 

(Response 37)—We agree that 

language similar to what the commenter 

suggested would be helpful, but we 

believe that the commenter’s change is 

more appropriate in the rulemaking 

pertaining to component part testing, 

specifically with component part testing 

for the lead content of children’s 

products under proposed 16 CFR 

1109.12. Therefore, we have considered 

this comment under the proposed rule 

for component part testing. 

On our own initiative, we have 

revised § 1107.20(c) to state: ‘‘Except 

where otherwise specified by a 

children’s product safety rule, 

component part testing pursuant to 16 

CFR part 1109 may be used to support 

the certification testing requirements of 

this section.’’ We made these changes to 

simplify the language in § 1107.20(c) 

and to remove descriptions of 16 CFR 

part 1109 to avoid potential confusion 

over what the final rule requires and 

what 16 CFR part 1109 mandates. 

(Comment 38)—One commenter 

stated that raw (or base) material testing 

is critical to its ability to develop 

programs to comply with the law. The 

commenter noted that, although it is a 

component manufacturer, it has more 

than 384,000 stock-keeping units 

(SKUs). These hundreds of thousands of 

products could be seen as different 

combinations of a smaller population of 

subcomponents and raw materials. The 

commenter stated that it is through 

working with this smaller population of 

subcomponents and raw materials that 

they can effectively manage quality in 

areas such as lead levels. 

(Response 38)—Component part 

testing of raw materials is beyond the 

scope of this rule and is considered in 

the final rule on Conditions and 

Requirements for Relying on Component 

Part Testing or Certification, or Another 

Party’s Finished Product Testing or 

Certification, to Meet Testing and 

Certification Requirements (16 CFR part 

1109). However, in that final rule, in 

many cases, raw materials or 

subcomponents may be considered 

component parts, as long as due care 

has been taken to ensure that no action 

subsequent to component part testing 

has adversely affected the raw materials’ 

or subcomponents’ compliance with the 

applicable product safety rules. 

d. Remedial Action 

Proposed § 1107.20(d) would state 

that, if a product sample fails 

certification testing, even if other 

samples have passed the same 

certification test, the manufacturer must 

investigate the reasons for the failure 

and take remedial action. A 

manufacturer would not be allowed to 

certify the children’s product until the 

manufacturer establishes with a high 

degree of assurance that the finished 

product complies with all applicable 

children’s product safety rules. 

(Comment 39)—Two commenters 

raised questions about what action must 

be taken when a product fails a test. One 

commenter interpreted the proposed 

rule to mean that all similar toys are 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69499 

also not compliant, resulting in a factory 

shutdown. The other commenter noted 

that different products vary in design 

and manufacture, and if one product 

fails, it does not mean that other 

products would have the same problem. 

(Response 39)—Section 1107.20(d) of 

the final rule states that if a product 

sample fails certification testing to the 

applicable children’s product safety 

rule(s), even if other samples have 

passed the same certification test, the 

manufacturer must investigate the 

reasons for the failure and take the 

necessary steps to address the reasons 

for the failure. Generally, certification 

testing of a children’s product requires 

all samples tested to pass the applicable 

children’s product safety standard. 

Otherwise, the certifier cannot ensure 

with a high degree of assurance that the 

tests conducted for certification 

purposes accurately demonstrate the 

ability of the children’s product to meet 

all applicable children’s product safety 

rules. However, some regulations allow 

for some individual samples of a test set 

to exceed the limit but still comply with 

the regulation. For example, in the 

Standard for the Surface Flammability 

of Small Carpets and Rugs (FF 2–70) in 

16 CFR part 1631, there is an allowance 

within the standard for a failure during 

a test and a prescribed action. Because 

the regulation specifies the procedure 

for dealing with a sample test failure, or 

through labeling, we would view such 

a properly labeled product as meeting 

the applicable product safety standard. 

A test failure for one children’s 

product applies only to that product and 

is not necessarily representative of all 

products in the factory. An exception to 

this might be a test on a component part 

used in many products. In that 

circumstance, the nature of the test 

failure and the component part’s use in 

the other products would affect which 

products the failing test result applies. 

For example, if a component part over 

the lead content limit is inaccessible, 

the use of that component part would 

not make the children’s product 

noncompliant. 

Additionally, on our own initiative, 

we have revised § 1107.20(d) by adding 

the phrase: ‘‘to the applicable children’s 

product safety rule(s)’’ after the phrase 

‘‘if a product sample fails certification 

testing.’’ This change is for clarification 

purposes and is not intended to have a 

substantive effect on the final rule. We 

also replaced the phrase ‘‘take remedial 

action’’ with the phrase ‘‘take the 

necessary steps to address the reasons 

for the failure’’ because we have 

removed the remedial action plan 

requirement in § 1107.25 from the final 

rule. We discuss the removal of the 

remedial action plan requirement in 

part III.D.7. of this document, below. 

3. Proposed § 1107.21 Periodic Testing 

a. General Periodic Testing 

Requirements 

Proposed § 1107.21(a) would 

implement the periodic testing 

requirement in section 14(i)(2)(B)(i) 

(renumbered by H.R. 2715 from section 

14(d)(2)(B)(i)) of the CPSA by requiring 

each manufacturer to conduct third 

party periodic testing at least annually, 

except as otherwise provided in 

proposed § 1107.21(b) and (d), or as 

provided in regulations under this title. 

The proposal also would explain that 

manufacturers may need to conduct 

third party periodic tests more 

frequently than on an annual basis to 

ensure a high degree of assurance that 

the product being tested complies with 

all applicable children’s product safety 

rules and that more frequent third party 

periodic testing may help a 

manufacturer identify noncompliant 

products quicker and, as a result, may 

limit the scope of any potential product 

recall. In addition, more frequent third 

party periodic testing may reduce the 

manufacturer’s liability for civil 

penalties resulting from a noncompliant 

product, reduce potential damage to a 

manufacturer’s reputation, and increase 

the manufacturer’s confidence in the 

effectiveness of the third party periodic 

testing. 

(Comment 40)—One commenter 

asserted that the language of proposed 

§ 1107.21 is not explicitly limited to 

children’s products. The commenter 

recommended that the language in the 

final rule be revised so that the term 

‘‘manufacturer’’ is changed to the phrase 

‘‘manufacturer of a children’s product’’ 

to clarify that § 1107.21 applies only to 

children’s products. The commenter 

also stated that the same revision should 

be made throughout subpart C, 

wherever the term ‘‘manufacturer’’ 

appears without the qualifier ‘‘of a 

children’s product.’’ 

(Response 40)—We believe it is clear 

that Subpart C applies only to children’s 

products. While we believe the 

commenter’s suggested change is 

unnecessary, we have made other 

revisions to the text and have added a 

reference to manufacturers of children’s 

product in § 1107.21(a) of the final rule 

to reiterate that the requirement applies 

only to children’s products. 

On our own initiative, we have 

revised § 1107.21 to reflect changes to 

the periodic testing frequency in 

§ 1107.21(b), (c), and (d) of the final 

rule, to mention component part testing, 

and to make nonsubstantive 

clarifications. For example, § 1107.21(a) 

of the final rule states: ‘‘All periodic 

testing must be conducted by a third 

party conformity assessment body.’’ The 

proposed rule had mentioned third 

party testing in proposed § 1107.21(b), 

but not in proposed § 1107.21(a), so 

adding this sentence to a revised 

§ 1107.21(a) of the final rule reinforces 

the notion that periodic testing of 

children’s products must be done by a 

third party conformity assessment body. 

We have reorganized § 1107.21 to state 

the general requirements at § 1107.21(a) 

and then identify different options for 

third party periodic testing frequencies 

at § 1107.21(b), (c), and (d). Thus, for 

example, we have modified and moved 

the annual periodic testing mentioned 

in proposed § 1107.21(a) to § 1107.21(b) 

in the final rule, and we have combined 

it with the periodic test elements that 

were at proposed § 1107.21(c). 

Consequently, § 1107.21(b) of the final 

rule states that a manufacturer must 

conduct third party periodic testing to 

ensure compliance with the applicable 

children’s product safety rules at least 

once a year, except as otherwise 

provided in § 1107.21(c) and (d), or as 

provided in our regulations. (The final 

rule states that the periodic testing 

under § 1107.21(b) must be done ‘‘once 

a year,’’ as opposed to ‘‘annually,’’ to 

eliminate potential confusion in 

determining how to calculate the proper 

interval for periodic testing.) Under 

§ 1107.21(b), the manufacturer must 

conduct periodic testing at least once a 

year when using a periodic test plan. 

Section 1107.21(b)(1) of the final rule 

(regarding the periodic test plan) is 

substantially the same as proposed 

§ 1107.21(c)(1), except that the final rule 

states that manufacturers must develop 

a periodic test plan to ‘‘ensure with a 

high degree of assurance’’ that 

children’s products continue to comply 

with all applicable children’s product 

safety rules. (The proposed rule stated 

that the manufacturer must develop a 

periodic test plan to ‘‘assure that 

children’s products’’ continue to 

comply.) Section 1107.21(b)(2), ‘‘Testing 

Interval,’’ is substantially the same as 

proposed § 1107.21(c)(2), except that, 

for consistency, the final rule refers 

simply to a ‘‘testing interval,’’ rather 

than a ‘‘periodic testing interval.’’ (The 

proposed rule had used different terms, 

such as ‘‘periodic testing interval,’’ 

‘‘testing interval,’’ ‘‘interval,’’ and 

‘‘interval for periodic testing,’’ for the 

same concept.) 

(Comment 41)—One commenter 

supported third party testing for the 

initial certification for any new products 

and said that any major changes in 


emcdonald on DSK5VPTVN1PROD with RULES3
69500 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

design, critical component changes, or 

meeting changing regulations should 

require recertification by third party 

testing bodies. The commenter also 

supported periodic testing by third 

party conformity assessment bodies of 

any products, providing that a much 

more refined and more specific 

requirement can be presented and 

confirmed by a proper authority. The 

commenter noted that it would be 

difficult and extremely risky to leave 

such a decision and ruling to the related 

parties. However, the commenter 

supported the earlier proposal of 

component part testing that certifies 

recognized components for toy 

production because it would enhance 

the elimination of certain repetitive and 

redundant testing on the finished 

product. 

(Response 41)—The commenter was 

unclear what it meant by a ‘‘proper 

authority’’ or which parties are the 

‘‘related parties’’ dealing with the 

difficulty and risk of periodic testing. In 

the final rule, the certifier (domestic 

manufacturer or importer) of a 

children’s product must determine the 

frequency of periodic testing and the 

number of samples to be tested. The 

frequency of testing (within specified 

maximum periodic testing intervals) 

and the number of samples required 

must be sufficient to give the certifier a 

high degree of assurance that continuing 

production or importation of the 

children’s product continues to meet the 

requirements of all applicable children’s 

product safety rules. 

The commenter did not indicate what 

factors should be added to the periodic 

testing requirements to make them more 

refined or specific. Thus, we have no 

basis to modify the rule to account for 

such factors. Further, identifying or 

creating a ‘‘proper authority’’ to confirm 

periodic testing programs would present 

practical difficulties due to the number 

of products requiring periodic testing 

plans and the variety of manufacturing 

techniques used in their production. 

Because periodic testing requirements 

apply to many different types of 

children’s products and manufacturers, 

and because manufacturing techniques 

for those products vary widely, one set 

of refined or specific requirements for 

periodic testing is unlikely to be 

applicable to all children’s products that 

require periodic testing. 

(Comment 42)—One commenter 

noted that some children’s products are 

not produced on a regular basis, and 

more than one year may pass between 

production runs. Because there are no 

production units on which to perform 

periodic testing, the commenter 

suggested that an ‘‘Inactive’’ product 

status be created for a children’s 

product that has passed certification 

testing—but currently is not being 

produced. Once production resumes, 

periodic testing can be performed on the 

new units. 

(Response 42)—A new ‘‘Inactive’’ 

status is unnecessary because periodic 

testing of children’s products is only 

required for continuing production after 

certification. If, in the commenter’s 

example, more than a year passes 

between production runs, when 

production recommences, the final rule 

requires periodic tests on new 

production runs to assure continued 

compliance. The certifier must use due 

care to ensure that no material change 

has occurred in the product’s design or 

manufacturing process, including the 

sourcing of component parts. Otherwise, 

new certification tests must be 

conducted on the newly manufactured 

product. 

(Comment 43)—One commenter 

noted that while the proposed rule 

would accept the use of component part 

testing for certification purposes, it does 

not address its use for periodic testing. 

The commenter would revise proposed 

§ 1107.21(c)(1) to include language 

allowing for the use of a component part 

testing program to meet the periodic 

testing requirements. The commenter 

stated that it could foresee customers 

requiring the development of a periodic 

testing program as a contractual 

requirement. 

Another commenter remarked that the 

proposed rule does not recognize items 

that are exempt from testing pursuant to 

16 CFR 1500.91, Determinations 

regarding lead content for certain 

materials or products under section 101 

of the Consumer Product Safety 

Improvement Act. 

(Response 43)—Section 1107.21(a) of 

the final rule states that manufacturers 

must conduct third party periodic 

testing. This testing is to ensure that 

children’s products manufactured after 

the issuance of a Children’s Product 

Certificate, or since the previous 

periodic testing was conducted, 

continue to comply with all applicable 

children’s product safety rules. Periodic 

testing can use component part testing 

to ensure compliance with some or all 

of the applicable children’s product 

safety rules. We have clarified the 

language of § 1107.21(a) of the final rule 

to state that component part testing may 

be used to meet the periodic testing 

requirements, subject to the conditions 

of § 1107.21. 

Regarding items that are exempt from 

testing for lead content, those items are 

also exempt from any periodic testing 

requirements. In 16 CFR 1500.91, we 

have determined that these materials 

fall under the lead content limit, and no 

testing is required. 

(Comment 44)—One commenter 

stated that the testing frequency should 

be left to the manufacturer and to the 

market; and the commenter further 

asserted that a rule requiring 

manufacturers to test according to these 

standards every year is an unaffordable 

economic burden. The commenter 

indicated that it is unrealistic to imagine 

that testing cost savings from 

maintaining a reasonable testing 

program (as described in the proposed 

rule) will be useful because that 

program is ‘‘wasteful and gargantuan.’’ 

The commenter asserted that a 

firewalled conformity assessment body 

would be unrealistic for small 

businesses. The commenter also 

maintained that component part and 

composite testing likewise, will provide 

no relief. The commenter asked: If a 

firm has a good long-term record of 

safety, then why are they required to 

test according to the proposed rule? 

(Response 44)—Section 14(i)(2)(B)(i) 

of the CPSA requires us to establish 

protocols and standards for ensuring 

that children’s products are subject to 

testing periodically. We have revised 

§ 1107.21 to allow third party periodic 

testing: At least once per year for 

children’s product with a periodic 

testing plan; at least once every two 

years for children’s products with a 

production testing plan; or at least once 

every three years for a production 

testing plan using an ISO/IEC 

17025:2005-accredited testing laboratory 

(and provided other requirements are 

met, including, but not limited to, using 

that lab to test to the children’s product 

safety rule(s) to which the product is 

subject). Allowing firms with a good 

long-term record of safety to forego 

testing their children’s products would 

not comply with the law, which 

requires periodic testing of children’s 

products, regardless of past 

performance. 

Regarding the commenter’s assertion 

that children’s product manufacturers 

will not attempt to save on testing costs 

because implementing a reasonable 

testing program is ‘‘wasteful and 

gargantuan,’’ the final rule does not 

require manufacturers of children’s 

products to have a reasonable testing 

program in order to save on third party 

conformity assessment body testing 

costs. By increasing the manufacturer’s 

options to qualify for an extension of the 

maximum periodic testing interval, we 

hope that more manufacturers wishing 

to implement such a program will find 

it advantageous to do so. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69501 

Additionally, pursuant to H.R. 2715, 

elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking comment on other techniques 

for lowering the cost of third party 

testing, consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 

As for the commenter’s remark about 

firewalled conformity assessment 

bodies, the final rule does not require 

that small businesses have a firewalled 

conformity assessment body. 

Finally, regarding the commenter’s 

statements on component part and 

composite part testing, we address those 

comments in the preamble to the final 

rule, Conditions and Requirements for 

Relying on Component Part Testing or 

Certification, or Another Party’s 

Finished Product Testing or 

Certification, to Meet Testing and 

Certification Requirements (16 CFR part 

1109). 

(Comment 45)—One commenter 

stated that periodic testing is 

unnecessary because when a product is 

manufactured in China, the initial 

product sample is inspected by the 

China Entry-Exit Inspection and 

Quarantine Bureau to ensure that it 

complies with all European Union, 

United States, and China product safety 

standards. Additionally, the commenter 

observed, the China Entry-Exit 

Inspection and Quarantine Bureau will 

conduct the random sample in-line 

inspection to inspect a number of 

samples in the production twice a year. 

The commenter said that products that 

fail the inspection will not be allowed 

to be exported. The commenter said that 

the strict product safety inspections by 

China Entry-Exit Inspection and 

Quarantine Bureau are enough to have 

the high degree of product safety 

assurance and that a periodic testing 

requirement would be duplicative. 

The commenter also said that periodic 

testing was unnecessary because, as the 

manufacturer, they have a high degree 

of self-discipline and strictly supervise 

their products’ safety. Furthermore, the 

commenter stated that 90 percent of 

manufacturers have their own testing 

laboratories that conform to 

international laboratory standards and 

already have a series of internal product 

safety testing in place to maintain a high 

degree of product safety and quality 

assurance. In addition, the commenter 

stated that most customers require 

testing by the third party conformity 

assessment body per order before the 

manufacturer exports the goods to 

ensure a high degree of product safety. 

(Response 45)—The final rule requires 

periodic testing to be conducted by a 

CPSC-accepted third party conformity 

assessment body. China Entry-Exit 

Inspection and Quarantine Bureaus do 

not currently meet the conditions 

specified in the Consumer Product 

Safety Improvement Act for 

governmental conformity assessment 

bodies to participate in the CPSC’s 

program. Further, the third party testing 

requirements apply irrespective of the 

level of a manufacturer’s selfsupervision of product safety. 

With regard to internal testing 

facilities, these are considered first party 

laboratories, and their tests are not 

allowed for periodic test purposes, 

unless the laboratory is a CPSC-accepted 

firewalled conformity assessment body. 

However, if the third party laboratories 

testing the manufacturer’s products for 

the customer are CPSC-accepted for the 

scope of the testing, test results from 

those laboratories may be used for 

fulfilling the periodic testing 

requirements. We note that internal 

testing facilities can be used to extend 

the maximum testing interval for 

periodic testing from one year to two 

years. Further, if the internal testing 

facility is ISO/IEC 17025:2005- 

accredited and other conditions are met, 

the maximum testing interval for 

periodic testing is extended to three 

years. 

(Comment 46)—One commenter 

stated that the importer who purchases 

a product from a manufacturer and takes 

possession of the product prior to 

importation does not have full visibility 

and knowledge of the manufacturing 

process and must treat each shipment 

produced by the manufacturer as a 

discrete lot. 

(Response 46)—An importer is 

responsible for issuing a Children’s 

Product Certificate for the children’s 

products they import. If a foreign 

manufacturer tests or certifies a 

children’s product and provides the 

importer with the test results or 

certificate and other required 

documentation, then the importer, 

exercising due care, using the 

manufacturer’s test data or certificate as 

a basis, may issue its own Children’s 

Product Certificate. 

In this circumstance, due care by the 

importer involves ensuring that the 

foreign manufacturer conducts periodic 

tests. If the foreign manufacturer does 

not certify the children’s product, but 

the importer has documentation of the 

manufacture and testing of the 

children’s product, then the importer is 

responsible for certifying the children’s 

product and is subject to the 

requirement for periodic testing. 

However, if the importer has no 

knowledge of the manufacture of the 

product, then it should treat each 

shipment as a discrete lot and subject it 

to certification testing because the 

importer does not know whether 

material changes have been made to the 

product since its last shipment. In this 

circumstance, the shipment that has 

undergone certification testing is not 

considered continuing production of the 

product, and is not subject to the 

periodic testing requirements. 

b. Periodic Testing and Reasonable 

Testing Programs 

Proposed § 1107.21(b) would state 

that if a manufacturer has implemented 

a reasonable testing program, as 

described in subpart B of this part (with 

the exception of the certification 

element which, for children’s products, 

would have to comply with the 

requirements in proposed § 1107.20), it 

would have to submit samples of its 

product to a third party conformity 

assessment body for periodic testing to 

all applicable children’s product safety 

rules at least once every two years. If a 

manufacturer’s reasonable testing 

program fails to provide a high degree 

of assurance of compliance with all 

applicable children’s product safety 

rules, proposed § 1107.21(b) would state 

that we may require the manufacturer to 

meet the periodic testing requirements 

in proposed § 1107.21(c) or modify their 

reasonable testing program to ensure a 

high degree of assurance. One element 

of the reasonable testing program in 

proposed subpart B would be the 

‘‘production testing plan’’ in proposed 

§ 1107.10(b)(3); a production testing 

plan would describe what tests must be 

performed and the frequency with 

which those tests must be performed to 

provide a high degree of assurance that 

the products manufactured after 

certification continue to meet all 

applicable safety rules, bans, standards, 

or regulations. 

(Comment 47)—One commenter 

recommended that we require children’s 

products to be tested by a third party 

conformity assessment body at least 

every year, not every two years, as 

proposed. The commenter felt that 

many changes can occur over time in 

the manufacturing process, materials, 

test standards, and test protocols that 

could cause products tested 

infrequently to drift away from 

compliance with applicable children’s 

product safety rules. The commenter felt 

that more frequent independent testing 

would be able to keep this in check 

better. 

(Response 47)—We disagree with the 

commenter’s inference that a production 

testing plan will not be capable of 

detecting ‘‘drift’’ in a product’s 


emcdonald on DSK5VPTVN1PROD with RULES3
69502 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

compliance with the applicable safety 

rules. We are aware of numerous forms 

of production testing techniques that 

have been implemented successfully to 

control product quality and ensure 

continuing compliance. 

Manufacturers are free, however, to 

test their products more frequently than 

the rule would require. 

Additionally, on our own initiative, 

we have reorganized § 1107.21 to move 

the requirements that were at proposed 

§ 1107.21(b) to § 1107.21(c) of the final 

rule. Furthermore, because we have 

reserved subpart B (which would 

pertain to a reasonable testing program), 

we have removed references to a 

‘‘reasonable testing program’’ in subpart 

C and replaced them with the key 

element of the ‘‘reasonable testing 

program,’’ which is the ‘‘production 

testing plan.’’ We decided to maintain 

the requirement for a production testing 

plan because children are a vulnerable 

population, and traditionally, we have 

had a greater interest in ensuring the 

safety of children’s products. 

Additionally, with the passage of the 

CPSIA, Congress indicated that it 

intended for children’s products to be 

subject to more stringent requirements 

than non-children’s products, as 

demonstrated by the requirements for 

third party testing and the protocols and 

standards for continuing third party 

testing for children’s products 

promulgated in this rulemaking. 

Section 1107.21(c)(1) of the final rule 

states that if a manufacturer implements 

a production testing plan, as described 

in § 1107.21(c)(2), to ensure continued 

compliance of the children’s product 

with a high degree of assurance to the 

applicable children’s product safety 

rules, the manufacturer must submit 

samples of its children’s product to a 

third party conformity assessment body 

for periodic testing to the applicable 

children’s product safety rules at least 

once every two years. The 2-year period 

is derived from proposed § 1107.21(b) 

for manufacturers who have a 

reasonable testing program. Section 

1107.21(c)(1) further states that a 

manufacturer may consider the 

information obtained from production 

testing when determining the 

appropriate testing interval (up to two 

years) and the number of samples 

needed for periodic testing to ensure 

that there is a high degree of assurance 

that the other untested children’s 

products manufactured during the 

testing interval comply with the 

applicable children’s product safety 

rules. The preamble to the proposed 

rule noted: ‘‘[t]he appropriate periodic 

testing interval may vary for a 

manufacturer depending on the 

manufacturer’s knowledge of the 

product and its manufacturing 

processes’’ for the factors to consider 

when determining the periodic testing 

interval under proposed § 1107.21(c)(2) 

(renumbered to § 1107.21(b)(2) in the 

final rule) (75 FR at 28349). This 

concept applies equally to the 

information obtained from production 

testing. Information gained from 

production testing can be used to 

determine the appropriate testing 

interval (up to two years), and so we 

added this concept to § 1107.21(c)(1). 

Section § 1107.21(c)(2) of the final 

rule describes the production testing 

plan, and it is substantially the same as 

the production testing plan in proposed 

§ 1107.10(b)(3) (which is reserved in the 

final rule, along with the rest of subpart 

B). Section 1107.21(c)(2) explains that 

the production testing plan describes 

‘‘the production management 

techniques and tests that must be 

performed to provide a high degree of 

assurance that the products 

manufactured after certification 

continue to meet all the applicable 

children’s product safety rules.’’ It 

further explains that a production 

testing plan may include: recurring 

testing or the use of process 

management techniques, such as control 

charts, statistical process control 

programs, or failure modes and effects 

analyses (FMEAs), designed to control 

potential variations in product 

manufacturing that could affect the 

product’s ability to comply with the 

applicable children’s product safety 

rules. 

Section 1107.21(c)(2) also states that a 

manufacturer may use measurement 

techniques that are nondestructive and 

that are tailored to the needs of an 

individual product to ensure that a 

product complies with all applicable 

children’s product safety rules. Thus, 

the tests in a production testing plan 

under § 1107.21(c)(2) do not have to be 

the tests described in the applicable 

children’s product safety rule, and they 

do not have to be conducted by a CPSCaccepted third party conformity 

assessment body. However, the 

implementation of the production 

testing plan still requires some testing. 

Purely mathematical techniques, such 

as a Failure Modes and Effects Analysis 

only, or a computer simulation of the 

product alone, are not allowed. Purely 

mathematical techniques, without 

verifying measurements, may not 

characterize the product with sufficient 

fidelity to predict accurately its 

compliance to the applicable rules. 

Section 1107.21(c)(2) of the final rule 

has revised the requirement in proposed 

§ 1107.10(b)(3)(iii)(B), which stated: 

‘‘Any production test method used to 

conduct production testing must be as 

effective in detecting noncompliant 

products as the test used for 

certification’’ to ‘‘Any production test 

method used to conduct production 

testing must be effective in determining 

compliance’’ in the final rule. The 

language of the proposed rule could 

practically be interpreted to require the 

use of the test method mandated for 

certification because a manufacturer 

would be unclear about what ‘‘as 

effective’’ means and therefore, use the 

test method for certification. We 

changed the language in the final rule to 

clarify the point that production testing 

does not require the use of the test 

method for certification. Additionally, 

§ 1107.10(b)(3)(iii)(C) of the proposed 

rule would state: ‘‘If a manufacturer is 

uncertain whether a production test is 

as effective as the certification test, the 

manufacturer must use the certification 

test.’’ This provision has been 

eliminated from the final rule because it 

is no longer necessary after the above 

clarification that production testing 

does not require use of the test method 

for certification. 

Finally, § 1107.21(c)(3) of the final 

rule states that if a production testing 

plan fails to provide a high degree of 

assurance of compliance with the 

applicable children’s product safety 

rules, we may require the manufacturer 

to meet the requirements of § 1107.21(b) 

for a periodic testing plan to ensure a 

high degree of assurance of compliance. 

This is not a new requirement. Proposed 

§ 1107.21(b) had the same requirement 

for manufacturers with a reasonable 

testing program. Because we have 

removed the reasonable testing program 

and reserved subpart B in the final rule, 

the periodic testing requirement is no 

longer linked to the reasonable testing 

program. However, we have moved this 

requirement to the production testing 

plan option in § 1107.21(c)(3) and the 

ISO/IEC 17025:2005-accredited 

laboratories option in § 1107.21(d) of the 

final rule. 

(Comment 48)—A commenter 

strongly recommended that we 

recognize or endorse certain internal inhouse testing facilities that conform to 

ISO 17025:2000 standard. The 

commenter felt that this recognition 

would greatly expedite testing 

procedures and the time for certain 

required testing and reduce costs and 

lessen dependence on the third party 

conformity assessment bodies. Another 

commenter stated that we should 

recognize internal laboratories as a way 

to reduce dependence on third party 

conformity assessment bodies. The 

reasons for the suggestions include: 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69503 

Better monitoring of product safety, a 

desire to reduce testing costs, encourage 

other manufacturers to develop their 

own internal testing facilities, and 

promote continuous product 

improvements. 

(Response 48)—We recognize that 

using ISO/IEC 17025:2005-accredited 

laboratories for testing purposes 

provides an added measure of assurance 

to production testing. The laboratories 

are accredited by an independent body 

as competent to perform specified tests. 

They are also recognized as having 

instituted a management system that 

establishes procedures and properly 

maintains records. Laboratory 

accreditation also establishes controls 

concerning data integrity, equipment 

calibration, and procedures to resist 

undue influence over testing results. 

For these reasons, we have amended 

the final rule to include a new 

§ 1107.21(d), which provides a 

maximum periodic testing interval of 

three years for a manufacturer using an 

ISO/IEC 17025:2005-accredited 

laboratory for production testing 

purposes. The laboratory must be 

accredited by an ISO/IEC 17011:2004(E) 

(more commonly known as ISO/IEC 

17011:2004 and how it will be referred 

to in the preamble) (Conformity 

assessment—General requirements for 

accreditation bodies accrediting 

conformity assessment bodies) 

accreditation body, and must use the 

same test method(s) used for 

certification testing when conducting 

testing to ensure continued compliance. 

We chose the 3-year time period 

because: (1) Having a laboratory 

accredited by an independent body as 

competent to perform specified tests 

provides an additional measure of 

assurance in the accuracy and the 

integrity of the testing results; (2) a 

laboratory accredited to ISO/IEC 

17025:2005 must have implemented a 

management system that establishes and 

follows procedures, properly maintains 

records, and establishes controls 

concerning data integrity equipment 

calibration, and procedures to resist 

undue influence; and (3) using the same 

tests as the tests used for product 

certification provides a more direct 

assessment of compliance to the 

applicable children’s product safety 

rules than process control techniques. 

Section 1107.21(d)(1) of the final rule 

also states that manufacturers must 

conduct testing using the ISO/IEC 

17025:2005-accredited testing laboratory 

frequently enough to provide a high 

degree of assurance that the children’s 

product continues to comply with the 

applicable children’s product safety 

rules. In addition, section 1107.21(d)(1) 

of the final rule states that a 

manufacturer may consider the 

information obtained from testing 

conducted by an ISO/IEC 17025:2005- 

accredited testing laboratory when 

determining the appropriate testing 

interval and the number of samples for 

periodic testing that are needed to 

ensure that there is a high degree of 

assurance that the other untested 

children’s products manufactured 

during the testing interval comply with 

the applicable children’s product safety 

rules. 

Section 1107.21(d)(2) of the final rule 

states that if the continued testing 

described in § 1107.21(d)(1) fails to 

provide a high degree of assurance of 

compliance with all applicable 

children’s product safety rules, then we 

may require the manufacturer to comply 

with § 1107.21(b) or modify the testing 

frequency or number of samples 

required to ensure a high degree of 

assurance of continued compliance. 

Section 1107.21(d)(2) is substantially 

the same, in this respect, as proposed 

§ 1107.21(b), in requiring the use of 

other third party periodic testing 

options if a manufacturer’s testing 

program fails to provide a high degree 

of assurance of compliance, except that 

§ 1107.21(d)(2) refers to ‘‘continuing 

testing,’’ rather than a ‘‘reasonable 

testing program.’’ 

Section 1107.21(g) of the final rule 

describes the incorporation by reference 

of ISO/IEC 17025:2005 and ISO/IEC 

17011:2004, as required by the Director 

of the Federal Register. This 

incorporation by reference is necessary 

because § 1107.21(d)(1) references ISO/ 

IEC 17025:2005 and ISO/IEC 

17011:2004. 

(Comment 49)—Two commenters 

stated that periodic testing or auditing 

should be considered a regular internal 

function. One commenter stated that 

any manufacturer with qualified 

internal testing facilities should perform 

such duties easily and regularly to 

ensure product quality. Having a third 

party conformity assessment body 

conduct periodic testing would result in 

a significant cost impact and would 

create production delays and 

difficulties. The commenter suggested 

that we not specify the frequencies of 

testing under different manufacturing 

conditions. The commenter stated that 

product safety rules should apply to 

finished products. 

Another commenter noted that a 

consistently good product testing record 

should reflect the competency of 

qualified internal testing facilities and 

expertise. Accredited and qualified inhouse testing facilities should be able to 

handle this effectively and 

economically. The commenter noted 

that smaller manufacturers may have to 

use the services of third party 

conformity assessment bodies per the 

agreed schedule, which needs to be 

defined and specified. 

(Response 49)—The final rule requires 

periodic testing to be conducted by a 

CPSC-accepted third party conformity 

assessment body. If the ‘‘qualified 

internal testing facility’’ is a CPSCaccepted firewalled conformity 

assessment body, then tests from that 

conformity assessment body can be used 

for periodic testing purposes. 

Otherwise, an internal testing facility is 

considered a first party laboratory, and 

its test results would not be allowed for 

third party periodic testing purposes. 

Regarding the commenter’s assertion 

of significant costs, the commenter did 

not describe how third party testing 

would result in significant costs and 

production difficulties relative to 

internal testing. However, a 

manufacturer with internal testing 

facilities may use product test data from 

those facilities to increase its knowledge 

of the product and its manufacture, and 

thus, may reduce the number of samples 

required for periodic testing purposes as 

a means of controlling costs. Section 

1107.21(c)(1) of the final rule states that 

if a manufacturer has implemented a 

production testing plan, the maximum 

testing interval for periodic testing is 

extended to two years. Additionally, 

under § 1107.21(d)(1) of the final rule, if 

the manufacturer uses an ISO/IEC 

17025:2005-accredited testing laboratory 

for the production testing (and other 

requirements are met), the maximum 

testing interval is extended to three 

years. These methods may be used by a 

manufacturer to reduce the costs of 

third party conformity assessment body 

testing. (We explain the reasons for 

adding § 1107.21(d) to the final rule at 

part III.D.3.b. of the preamble.) 

We agree with the commenter on the 

undesirability of specifying testing 

frequencies for different manufacturing 

conditions. Thus, the final rule specifies 

only the maximum testing interval for 

periodic testing and lists some factors to 

be considered by manufacturers in 

developing their periodic test plans. We 

also agree with the commenter that 

product safety rules should apply to 

finished products. 

As noted above, pursuant to H.R. 

2715, elsewhere in this issue of the 

Federal Register, we have published a 

notice seeking public comment on other 

techniques for lowering the cost of third 

party testing consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 


emcdonald on DSK5VPTVN1PROD with RULES3
69504 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

(Comment 50)—One commenter said 

we should clarify what level of detail or 

generality we would allow in mandating 

that a production test plan describe the 

tests to be conducted or the 

measurements to be tested. The 

commenter assumed that a 

manufacturer would have the flexibility 

to create a test plan that could be 

applied to multiple products. For 

example, the commenter suggested that 

a production testing plan could address 

testing by generic specifications of 

products, such as die-cast cars or 

fashion dolls. However, the commenter 

said that if we expect a production 

testing plan to specify the testing details 

for each product, then it would be so 

burdensome as to be economically not 

feasible. 

(Response 50)—The use of production 

testing as a means to increase the 

maximum periodic test interval to two 

years is intended to be general in nature 

and flexible enough to be adaptable to 

many different products and 

manufacturing processes. It is the 

manufacturer’s responsibility to tailor 

its production testing to its specific 

products. As stated in § 1107.21(c)(2) of 

the final rule, production testing is 

intended to ensure continued 

compliance of the product to the 

applicable children’s product safety 

rules with a high degree of assurance. It 

is not required that a manufacturer’s 

production testing plan specify all 

testing details for each product. 

However, § 1107.21(c)(2)(i) of the final 

rule specifies that a production testing 

plan must include a description of the 

process management techniques used, 

the tests to be conducted, or the 

measurements to be taken; the intervals 

at which the tests or measurements will 

be made; the number of samples tested; 

and the basis for determining that the 

combination of process management 

techniques and tests provide a high 

degree of assurance of compliance if 

they are not the tests prescribed for the 

applicable children’s product safety 

rule. This is necessary because 

techniques and test methods other than 

those prescribed in the applicable 

children’s product safety rules may be 

used in production testing and are 

needed to show the effectiveness of the 

production testing plan. 

(Comment 51)—Two commenters 

stated that, although we acknowledged 

that a production testing plan could 

include procedures such as process 

management techniques, statistical 

process control programs, or failure 

mode analysis, the proposed rule would 

describe a rather rigid product testing 

plan. One commenter characterized the 

following two requirements as ‘‘a rigid 

product testing plan’’: (1) The 

requirement for each site to have a 

separate production testing plan, and (2) 

the production testing interval should 

be short enough to ensure that, if the 

samples selected for production testing 

comply with an applicable rule, ban, 

standard, or regulation, there is a high 

degree of assurance that the untested 

product will comply with the applicable 

rule, ban, standard, or regulation. The 

commenter urged us to acknowledge 

more clearly that the elements of a 

production test plan enumerated in the 

rule are not the only elements that we 

will recognize and that other processes, 

such as statistical process control 

mechanisms, also may be used to show 

compliance. 

One commenter suggested that the 

terms ‘‘production testing plan’’ and 

‘‘remedial action plan’’ be replaced with 

‘‘production testing plan or procedures’’ 

and ‘‘remedial action plan or 

procedures’’ because the use of the word 

‘‘plan’’ may be interpreted too narrowly 

to allow for the range of methods that 

manufacturers may use to meet the 

requirements. 

(Response 51)—Manufacturers may 

use production testing plans with any 

procedure that is effective in detecting 

noncompliant products (with the 

requirement that purely mathematical 

methods with no testing are not 

allowed). Statistical process control 

mechanisms, properly applied, are 

acceptable methods for production 

testing. The production testing plan 

implemented at each manufacturing site 

may be identical, if appropriate; but 

each site must have identifiable 

production testing specific to the 

products produced at that site. On our 

own initiative, we have added language 

to § 1107.21(c)(2)(ii) that clarifies this 

point. This is a matter of 

documentation, and the commenter has 

not provided a reason why this creates 

a problem. The final rule does not 

mandate a specific testing interval for 

all products. Rather, the requirement in 

the final rule is for production testing to 

be effective in detecting noncompliant 

products with whatever fixed or 

variable testing interval achieves a high 

degree of assurance of compliance to the 

applicable product safety rules. 

We decline to adopt the suggestion to 

change ‘‘production testing plan’’ to 

‘‘production testing plan or 

procedures.’’ Dictionary definitions of 

‘‘plan’’ and ‘‘procedure’’ are so similar 

that, to use both terms would be 

redundant. We believe that the 

description of a production testing plan 

in § 1107.21(c) of the final rule provides 

a sufficient description of its scope. 

Additionally, because the final rule 

does not require a remedial action plan 

for children’s products, the suggestion 

to replace the term ‘‘remedial action 

plan’’ with ‘‘remedial action plan or 

procedures’’ is no longer applicable. 

(Comment 52)—One commenter 

supported the acknowledgement that 

the same production testing plan that is 

available to the manufacturing site and 

the importer of record (retailers) is 

sufficient. The commenter gave the 

example of a manufacturer who 

developed a production testing plan and 

demonstrated to their customers (the 

importers of record or retailers) that 

their production testing plan provides a 

high degree of assurance of compliance. 

The commenter said that importers 

could validate critical aspects of the 

plan through factory audits and 

evaluations, production inspections that 

ensure that the testing plan records are 

present and match the specifications, 

and periodic testing using a CPSCaccepted third party conformity 

assessment body. 

(Response 52)—An importer can 

arrange for another party (e.g., a foreign 

manufacturer) to develop and conduct 

production testing for a product. The 

same production testing plan from 

another party may be used by multiple 

importers as a means of increasing the 

importers’ maximum periodic test 

interval to two years. The importer, as 

the product certifier, must use due care 

to ensure that the implementation of a 

production testing plan ensures with a 

high degree of assurance that continuing 

production complies with the 

applicable product safety rules. 

(Comment 53)—One commenter 

noted that proposed § 1107.21(b) would 

specify that if a manufacturer’s 

reasonable testing program fails to 

provide a high degree of assurance of 

compliance with all applicable 

children’s product safety rules, we may 

require the manufacturer to meet the 

requirements of proposed § 1107.21(c) 

or modify its reasonable testing program 

to ensure a high degree of assurance of 

compliance. The commenter asked who 

would determine whether a reasonable 

testing program provides a high degree 

of assurance of compliance, and how. 

(Response 53)—With regard to the 

language in proposed § 1107.21(b) 

referenced by the commenter, because 

we have reserved the reasonable testing 

program option for periodic testing in 

the final rule, we have moved that 

language to §§ 1107.21(c)(3) and (d)(2) 

(renumbered in the final rule) and 

modified it to refer to the production 

testing plan option with a maximum 

periodic testing interval of two years 

and/or the testing by an ISO/IEC 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69505 

17025:2005-accredited testing laboratory 

option with a maximum periodic test 

interval of three years. With these 

changes in mind, we will decide, based 

on the available evidence, whether a 

children’s product’s production testing 

plan provides a high degree of assurance 

of continuing compliance to the 

applicable children’s product safety 

rules. 

(Comment 54)—One commenter 

noted that the voluntary establishment 

of a reasonable testing program for a 

children’s product increases the period 

between periodic tests to—at least once 

every two years—from the requirement 

of annual periodic testing for children’s 

products without a reasonable testing 

program. The commenter suggested that 

we consider the costs involved in 

establishing and maintaining a 

reasonable testing program, and noted 

that a reasonable testing program 

reasonably warrants a more relaxed 

periodic testing frequency standard, 

particularly when the manufacturing 

process inherently results in uniform 

production, with very little variability 

in the composition or quality. 

The commenter also noted that the 

preamble to the proposed rule stated 

that not all periodic testing was required 

to be conducted by a third party 

conformity assessment body (75 FR at 

28348). In addition, the commenter 

pointed out that the preamble to the 

proposed rule also stated that the 

appropriate periodic testing interval 

‘‘may vary for a manufacturer 

depending on the manufacturer’s 

knowledge of the product and its 

manufacturing processes’’ (75 FR at 

28349). 

The commenter urged us to permit a 

manufacturer of a children’s product 

with a reasonable testing program in 

place to determine when to obtain third 

party conformity assessment body 

testing of ordinary children’s books or 

other children’s paper-based printed 

products under a testing frequency 

standard of at least once every four 

years. The commenter noted that third 

party conformity assessment body 

testing still would occur in response to 

a material change to the children’s 

product. 

(Response 54)—The final rule extends 

the maximum testing interval for 

periodic testing from one to two years 

for manufacturers who have 

implemented a production testing plan 

as a means of ensuring continued 

compliance of the product to the 

applicable children’s product safety 

rules. The production testing plan in 

§ 1107.21(c) of the final rule is the same 

production testing plan in the 

reasonable testing program described in 

proposed § 1107.10(b)(3). This increase 

in the maximum testing interval was not 

based on the costs of third party testing 

or on the costs of implementing a 

production testing plan. When a 

manufacturer implements a production 

testing plan and conducts production 

testing, such testing provides more 

information about a product’s 

manufacture and compliance with the 

applicable children’s product safety 

rules, which justifies allowing a longer 

period of time between third party 

periodic tests. If a manufacturer uses an 

ISO/IEC 17025:2005-accredited testing 

laboratory for testing to assure 

continued compliance, the maximum 

third party periodic testing interval is 

extended to three years. 

The commenter is correct that the 

preamble to the proposed rule stated 

that not every periodic test has to be 

done by a third party conformity 

assessment body if the manufacturer has 

implemented four elements of a 

reasonable testing program. However, 

§ 1107.21(c) of the final rule states that 

a manufacturer who has implemented a 

production testing plan for a children’s 

product must submit samples of the 

product to a third party conformity 

assessment body for periodic testing at 

least once every two years. We 

recognize that these two statements may 

be confusing, and we have clarified the 

text in § 1107.21(a) of the final rule to 

state that all third party periodic testing 

must be conducted by a CPSC-accepted 

third party conformity assessment body 

accredited to the scope of the tests 

required. 

Additionally, on August 12, 2011, the 

President signed into law H.R. 2715 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires us 

to review the public comments and 

states that we may prescribe new or 

revised third party testing regulations if 

we determine that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

Regarding the commenter’s suggestion 

on testing ordinary children’s books or 

other children’s ordinary paper-based 

printed materials, section 14(i)(4) of the 

CPSA, as amended by H.R. 2715, 

excludes ordinary books from the third 

party testing requirements in section 

14(a) of the CPSA. Additionally, we 

have decided to reserve, rather than 

finalize, subpart B, which would have 

pertained to a reasonable testing 

program for nonchildren’s products. 

Therefore, it is unnecessary for us to 

address the commenter’s suggestion. 

c. Periodic Testing in the Absence of a 

Reasonable Testing Program 

Proposed § 1107.21(c) would state 

that if a manufacturer has not 

implemented a reasonable testing 

program, as described in subpart B of 

this part, then all periodic testing would 

be required to be conducted by a third 

party conformity assessment body, and 

the manufacturer would be required to 

conduct periodic testing, described in 

proposed § 1107.21(c)(1) and (c)(2). 

Proposed § 1107.21(c)(1) would 

require the manufacturer to develop a 

periodic testing plan to ensure that 

children’s products manufactured after 

issuance of a children’s product 

certification, or when the previous 

periodic testing was conducted, 

continue to comply with all applicable 

children’s product safety rules. 

Proposed § 1107.21(c)(2) would 

require the periodic testing interval 

selected to be short enough to ensure 

that, if the samples selected for periodic 

testing pass the test, then there is a high 

degree of assurance that the other 

untested children’s products 

manufactured during the interval 

comply with the applicable children’s 

product safety rules. The interval for 

periodic testing may vary, depending 

upon the specific children’s product 

safety rules that apply to the children’s 

product. Proposed § 1107.21(c)(2)(i) 

through (c)(2)(ix) listed factors to be 

considered when determining the 

periodic testing interval. 

On our own initiative, we made 

several editorial and complementary 

changes to proposed § 1107.21(c). In 

brief: 

• We have renumbered proposed 

§ 1107.21(c) as § 1107.21(b) in the final 

rule. 

• In § 1107.21(b), we have revised the 

text to state the periodic testing options 

more clearly. Section 1107.21(b) now 

states that a manufacturer ‘‘must 

conduct periodic testing to ensure 

compliance with the applicable 

children’s product safety rules at least 

once a year,’’ except as otherwise 

provided in § 1107.21(c) and (d) (the 

other periodic testing options in the 

final rule), or as provided in regulations 

under this title. Section 1107.21(b) of 

the final rule further states that if a 

manufacturer does not conduct 


emcdonald on DSK5VPTVN1PROD with RULES3
69506 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

production testing under § 1107.21(c), 

or testing by a testing laboratory under 

§ 1107.21(d), the manufacturer must 

conduct periodic testing pursuant to the 

periodic test plan requirements at 

§ 1107.21(b)(1) and the testing interval 

requirements in § 1107.21(b)(2). 

• In § 1107.21(b)(1) (formerly 

proposed § 1107.21(c)(1)), we have 

replaced ‘‘assure’’ with ‘‘ensure with a 

high degree of assurance.’’ We made this 

change to be consistent with other 

language used throughout the final rule. 

We also replaced ‘‘children’s product 

certification’’ with ‘‘Children’s Product 

Certificate,’’ for consistency throughout 

the final rule, and we eliminated the 

requirement of providing a basis for 

determining that the periodic testing 

plan provides a high degree of assurance 

that the product being tested continues 

to comply with all applicable children’s 

product safety rules. We eliminated the 

requirement that a manufacturer 

provide the basis for determining that a 

periodic test plan provides a high 

degree of assurance because 

manufacturers would need to 

demonstrate how their production 

testing plan provides a high degree of 

assurance if we requested that 

information. However, it is 

unnecessarily burdensome to require a 

manufacturer to provide the basis for 

this in every instance, when we may 

never inquire about the basis for a 

particular periodic test plan. Therefore, 

we have eliminated this requirement 

from the final rule. In addition, we have 

added language to § 1107.21(b)(1) to 

clarify that a manufacturer must have a 

periodic testing plan specific to each 

children’s product manufactured at a 

manufacturing site. 

• In § 1107.21(b)(2) (pertaining to 

testing intervals), we have revised the 

text to refer to ‘‘testing interval’’ or 

‘‘testing,’’ instead of ‘‘periodic testing 

interval’’ or ‘‘periodic testing.’’ ‘‘Testing 

Interval,’’ is substantially the same as 

proposed § 1107.21(c)(2), except that, 

for consistency, the final rule refers 

simply to a ‘‘testing interval,’’ rather 

than a ‘‘periodic testing interval.’’ (The 

proposed rule had used different terms, 

such as ‘‘periodic testing interval,’’ 

‘‘testing interval,’’ ‘‘interval,’’ and 

‘‘interval for periodic testing,’’ for the 

same concept.) We removed the word 

‘‘periodic’’ because it is redundant in 

the context of the section, which 

addresses ‘‘periodic testing.’’ 

Additionally, § 1107.21(b)(2) states that 

the testing interval may vary, depending 

upon the specific children’s product 

safety rules that apply to the children’s 

product, ‘‘but may not exceed one year.’’ 

We added ‘‘but may not exceed one 

year’’ to clarify that, consistent with 

§ 1107.21(b), the periodic testing must 

occur at least once a year. 

• Section 1107.21(b)(2)(i) through (x) 

lists the factors to be considered in 

determining the testing interval. This 

list is almost identical to proposed 

§ 1107.21(b)(2)(i) through (ix), except 

that the final rule separates the 

examples of nonmaterial changes that 

were at proposed § 1107.21(b)(2)(v). 

Proposed § 1107.21(b)(2)(v) would 

mention ‘‘Nonmaterial changes, such as 

introduction of a new set of component 

parts into the assembly process, or the 

manufacture of a fixed number of 

products.’’ Upon further consideration, 

we felt that the two examples were 

dissimilar, so § 1107.21(c)(2)(v) of the 

final rule now states: ‘‘Introduction of a 

new set of component parts into the 

assembly process’’; and 

§ 1107.21(c)(2)(vi) of the final rule 

states: ‘‘The manufacture of a fixed 

number of the products.’’ We have 

renumbered the remaining 

subparagraphs in § 1107.21(c)(2), 

accordingly. 

d. Periodic Testing Frequency for LowVolume Manufacturers 

Proposed § 1107.21(d) would pertain 

to the periodic testing frequency for 

low-volume manufacturers. In brief, the 

proposal would not require a 

manufacturer to conduct periodic 

testing unless it has produced or 

imported more than 10,000 units of a 

particular product; instead, once that 

threshold has been reached, the 

manufacturer would be subject to the 

periodic testing requirements of 

proposed § 1107.21(a), and (b), or (c). 

Several commenters addressed 

proposed § 1107.21(d). The comments 

spanned a range of issues. For example, 

one commenter said that the production 

or importation volumes for different 

children’s products may vary 

substantially, such as large electrical 

motorcycles and small stuffed toys, so 

the commenter said it is not reasonable 

to apply the same volume of 10,000 to 

all children’s products. The commenter 

asked whether periodic testing is 

necessary when a large number of 

products are produced in a short 

timeframe, for example, 100,000 toys 

produced in three months. Other 

commenters also focused on the 10,000 

figure, asking whether the figure applies 

only to the number of children’s 

products produced, whether the number 

applies to each distinct product or to all 

children’s products made at a facility, or 

whether the figure of 10,000 units is too 

high or too low. (One commenter stated 

that its analysis of CPSC-announced 

recalls in 2009, showed that 47 percent 

of the recalls involved products of 

10,000 units or less.) Yet another 

commenter interpreted the provision as 

an acknowledgement by the CPSC that 

the periodic testing frequency standard 

is not essential to safety because it 

dispenses with periodic testing 

altogether in the case of manufacturers 

who produce or import no more than 

10,000 units of a product. 

On August 12, 2011, the President 

signed H.R. 2715 into law. H.R. 2715 

requires, among other things, that we 

seek public comment on opportunities 

to reduce the cost of third party testing 

requirements consistent with assuring 

compliance with any applicable 

consumer product safety rule, ban, 

standard, or regulation. It also contains 

special rules for small batch 

manufacturers and directs us to 

consider alternative testing 

requirements or exempt small batch 

manufacturers from certain third party 

testing requirements. Given these new 

statutory obligations resulting from H.R. 

2715, and, as part of the overall 

reorganization of § 1107.21, proposed 

§ 1107.21(d) is being renumbered and 

reserved as § 1107.21(e), so that we may 

consider issues relating to cost, lowvolume products, and small batch 

manufacturers more fully. 

We are also reserving § 1107.21(f) for 

an amendment to this rule where, 

elsewhere in this issue of the Federal 

Register, we have published a proposed 

rule that would implement the 

‘‘representative samples’’ provision in 

section 14(i)(2)(B)(ii) of the CPSA. 

4. Proposed § 1107.22—Random 

Samples 

Proposed § 1107.22 would implement 

the testing of random samples 

requirement in former section 

14(d)(2)(B)(ii) of the CPSA (renumbered 

by H.R. 2715 as section 14(i)(2)(B)(ii) of 

the CPSA), by requiring each 

manufacturer of a children’s product to 

select samples for periodic testing by 

using a process that assigns each sample 

in the production population an equal 

probability of being selected. 

We received many comments on 

proposed § 1107.22. The commenters 

made numerous assertions, such as: 

Product samples should be reasonably 

representative of the product 

population; samples should not be 

golden samples; samples should be 

selected blindly; samples should not be 

selected with overt bias; and the rule 

should not use a statistical definition for 

random sample. Commenters also 

expressed concern over practical 

problems with the proposed section for 

random sampling. However, on August 

12, 2011, the President signed H.R. 2715 

into law. H.R. 2715 revised section 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69507 

14(i)(2)(B)(ii) of the CPSA, by replacing 

testing of ‘‘random samples’’ to ensure 

continued compliance with testing of 

‘‘representative samples’’ to ensure 

continued compliance. Given this 

change in the statute, we have removed 

§ 1107.22 from the final rule. Elsewhere 

in this issue of the Federal Register, we 

have published a proposed rule that 

would implement the ‘‘representative 

samples’’ provision in H.R. 2715. 

5. Proposed § 1107.23—Material Change 

a. General Requirements 

Proposed § 1107.23(a) would state 

that if a children’s product undergoes a 

material change in product design or 

manufacturing process, including the 

sourcing of component parts, that a 

manufacturer exercising due care knows 

or should know that such material 

change could affect the product’s ability 

to comply with the applicable children’s 

product safety rules, the manufacturer 

must submit a sufficient number of 

samples of the materially changed 

product for testing by a third party 

conformity assessment body. Such 

testing would be required before a 

manufacturer could certify the 

children’s product. The extent of such 

testing would depend on the nature of 

the material change. Proposed 

§ 1107.23(a) also would state that, when 

a material change is limited to a 

component part of the finished 

children’s product and does not affect 

the ability of the children’s product to 

meet other applicable children’s 

product safety rules, a manufacturer 

may issue a Children’s Product 

Certificate based on the earlier third 

party certification tests and on test 

results of the changed component part 

conducted by a third party conformity 

assessment body. For example, if the 

paint is changed on a children’s 

product, issuance of a Children’s 

Product Certificate may be based on 

previous product testing and on tests of 

the new paint for compliance to lead, 

heavy metal, and phthalate 

concentrations. Proposed § 1107.23(a) 

also would state that changes that cause 

a children’s product safety rule to no 

longer apply to a children’s product are 

not considered to be material changes. 

For example, assume that a children’s 

product consists of a cotton sweater 

with metal buttons and that the 

children’s product would be subject to 

the lead limits in section 101 of the 

CPSIA. If the manufacturer decided to 

use wooden buttons instead of metal 

buttons, the use of wooden buttons 

would eliminate the need to test the 

product for lead, and the change to 

wooden buttons, while arguably a 

change in the product’s component 

parts, would not be a ‘‘material change’’ 

under proposed § 1107.23(a) for the 

purposes of complying with the lead 

content limits. However, for other 

children’s product safety rules, such as 

small parts, the change may be a 

material change. 

Additionally, proposed § 1107.23(a) 

would require a manufacturer to 

exercise due care to ensure that reliance 

on anything other than retesting of the 

finished product after a material change 

would not allow a noncompliant 

children’s product to be distributed in 

commerce. A manufacturer should 

resolve any doubts in favor of retesting 

the finished product for certification. A 

manufacturer also would be required to 

exercise due care to ensure that any 

component part undergoing componentpart-level testing is the same as the 

component part on the finished 

children’s product in all material 

respects. 

We received several comments 

regarding ‘‘material change’’ and 

proposed § 1107.23, as well as the 

corresponding provision at proposed 

§ 1107.10(b)(2)(ii). Although we have 

decided to reserve subpart B in the final 

rule, to the extent that comments on 

proposed § 1107.10(b)(2)(ii) were 

equally applicable to proposed 

§ 1107.23, we have considered those 

comments here. 

(Comment 55)—A commenter 

suggested that the definition of 

‘‘material change’’ should be moved 

from proposed § 1107.10(b)(2)(ii) to the 

definitions in § 1107.2. 

(Response 55)—Section 1107.10 has 

been reserved in the final rule. We agree 

with the commenter, and we have 

moved the definition of ‘‘material 

change’’ to § 1107.2 in the final rule, as 

this definition still applies to § 1107.23 

regarding material changes in children’s 

products. Thus, § 1107.2 defines 

‘‘material change’’ as ‘‘any change in the 

product’s design, manufacturing 

process, or sourcing of component parts 

that a manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations.’’ 

(Comment 56)—Some commenters 

suggested revising the proposed 

definition of ‘‘material change’’ to refer 

only to changes that ‘‘reasonably could 

affect’’ compliance. 

(Response 56)—The commenters are 

concerned about a remote possibility 

that some set of circumstances could 

combine, such that a seemingly 

innocuous change could affect the 

product’s compliance to an applicable 

product safety rule. We realize that it 

would be difficult for a manufacturer to 

identify every conceivable theoretical 

effect a change could have on a 

children’s product’s compliance. 

Therefore, manufacturers should 

exercise prudence and competence in 

determining the effects of a change to 

the product and in considering whether 

that change is material. This prudence 

and competence is encompassed in the 

manufacturer’s use of due care in 

evaluating the change. 

We decline the commenters’ 

suggestion to modify the definition of 

‘‘material change’’ because the 

definition now in § 1107.2 of the final 

rule includes the phrase ‘‘a 

manufacturer exercising due care.’’ 

Because the definition of ‘‘due care’’ 

includes the exercise of prudence and 

competence by the manufacturer, the 

addition of ‘‘reasonably could’’ is 

duplicative. 

(Comment 57)—One commenter 

stated that different versions of the same 

product (e.g., color, packaging) should 

not require different tests. 

(Response 57)—The commenter is 

correct that different versions of the 

same product that are not materially 

different do not require separate 

certification tests. The final rule defines 

a ‘‘material change’’ as any change in 

the product’s design, manufacturing 

process, or sourcing of component parts 

that a manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations. Therefore, if the differences 

between various versions of the same 

product are not material changes, no 

additional testing is required. It is the 

manufacturer’s responsibility to 

determine if a difference between 

versions of a product constitutes a 

‘‘material change.’’ 

(Comment 58)—One commenter 

suggested that after certification testing 

of a product, if another product differs 

by a few minor components from the 

certified product, and proper proof of 

equivalent specifications are 

documented, a reduced sample size for 

certification should be allowed. 

(Response 58)—In the circumstance 

described by the commenter, if a new 

product differs from an existing certified 

product by a few component parts, the 

manufacturer’s knowledge of the new 

product and its manufacture might be 

extensive enough to result in requiring 

fewer samples for certification testing 

than the number required for the 

existing certified product. We reiterate 

that if a new product is based on 

changes to an existing certified product, 

only the applicable product safety rules 

affected by the changes require 


emcdonald on DSK5VPTVN1PROD with RULES3
69508 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

certification testing. The number of 

samples still must be sufficient to give 

the manufacturer a high degree of 

assurance of the new product’s 

compliance with the applicable 

children’s product safety rules. The 

certifier also may use component part 

testing as a means of reducing the 

number of finished samples needed for 

certification. If the changes from the 

existing certified product to the newer 

product are not material, then the 

certification tests on the existing 

certified product can be used for 

certification purposes on the newer 

product. 

Thus, on our own initiative, we have 

revised § 1107.23(a) to make several 

clarifying changes to the paragraph. 

First, we have added language to the 

final rule to require the number of 

samples submitted to be sufficient to 

provide a high degree of assurance that 

the materially changed component part 

or finished product complies with the 

applicable children’s product safety 

rules. This language was added because 

third party testing that occurs after a 

material change serves as recertification 

of the product for the applicable 

children’s product safety rules affected 

by the material change. This language is 

essentially the same requirement 

contained in § 1107.20(a) of the final 

rule for initial certification of children’s 

products. Additionally, § 1107.23(a) was 

revised to add the following: ‘‘A 

manufacturer of a children’s product 

that undergoes a material change cannot 

issue a new Children’s Product 

Certificate for the product until the 

product meets the requirements of the 

applicable children’s product safety 

rules.’’ Also, we added the following 

words to the first sentence: ‘‘and issue 

a new Children’s Product Certificate.’’ 

These are not intended to be substantive 

changes, but rather, meant to make clear 

what is already the case—that material 

changes require recertification based on 

passing test results. Finally, we have 

removed the language in proposed 

§ 1107.23(a) that would require a 

manufacturer to exercise due care to 

ensure that reliance on anything other 

retesting of the finished product after a 

material change would not allow a 

noncompliant children’s product to be 

distributed in commerce. This provision 

was removed because this issue is 

addressed in § 1109.5(a)(1) of the 

accompanying component part testing 

rule. We also removed the requirement 

that a manufacturer should resolve any 

doubts in favor of retesting the finished 

product for certification. This provision 

was removed because the issue is 

addressed in § 1109.5(c) of the 

accompanying component part testing 

rule. 

(Comment 59)—Two commenters 

raised issues related to products subject 

to 16 CFR part 1201, Safety Standard for 

Architectural Glazing Materials, 

although the issues they raised have 

wider implications that involve other 

products, including children’s products. 

The products subject to that safety 

standard are glazing materials (glass) 

used or intended for use in doors and 

enclosures. The commenters noted that 

these types of glass normally are 

manufactured in a continuous process 

that is subject to numerous minor and 

ongoing adjustments to respond to 

atmospheric and other factors and to 

make sure that the tempering process 

continues properly. In addition, there 

can be numerous minor variations in 

format, size, and thickness of the glass, 

as well as other product characteristics 

that are a normal part of shifting from 

one product to another to meet 

customers’ orders. This industry’s 

current process of certification and 

quality control involves periodic third 

party ‘‘certification’’ testing to the 

requirements of 16 CFR part 1201 and 

uses alternate means for checking 

breakage performance of samples from 

subsequent production, such as a center 

punch test for tempered glass and the 

drop-ball and/or pummel test for 

laminated glass, in order to monitor 

ongoing compliance with the standard. 

If a potential failure of the standard is 

detected by these alternate tests, 

corrective action is taken, and product 

distribution is not resumed until a 

subsequent production test shows that 

the breakage performance has been 

restored. 

The commenters requested 

clarification that the ongoing 

adjustments described above would not 

be ‘‘material changes’’ that would 

require recertification of the product. 

The proposed rule defines ‘‘material 

change’’ as one that ‘‘could affect the 

product’s ability to comply with the 

applicable rules * * *’’ One commenter 

requested that we state: 

An adjustment to equipment or machinery 

made in order to maintain, achieve, or assure 

compliance with the applicable rules * * * 

is not a material change within the meaning 

of section 1107.10. 

The other commenter suggested the 

following addition to the rule: 

Adjustments in the equipment or 

machinery to affect the product’s ability to 

comply with any applicable rules or 

standards should not be considered a 

‘‘material change’’ in the manufacturing 

process * * * but will require the 

manufacturer, following those adjustments to 

subject the product to its production testing 

plan and to achieve passing production test 

results before the manufacturer may resume 

production of that product. 

(Response 59)—Although regulated 

non-children’s products still must meet 

the certification requirements in section 

14(a)(1) of the CPSA, we have reserved 

subpart B, including the reasonable 

testing program described in proposed 

§ 1107.10. However, the broader issue 

presented by this commenter, which 

relates to adjustments in equipment or 

machinery, is applicable to children’s 

products as well, so we will address this 

issue with regard to children’s products. 

In order for a change to be a ‘‘material 

change,’’ it should be one that could 

adversely affect the product’s ability to 

comply with the rule, ban, standard, or 

regulation. Minor and ongoing 

adjustments during manufacturing, 

especially in continuous flow processes, 

to maintain compliance with the 

applicable product safety rules are not 

considered material changes. However, 

we do not agree entirely with the 

commenters’ suggested language 

because that language would include 

adjustments made to ‘‘achieve’’ 

compliance (i.e., to change a product 

from noncompliance to compliance). 

Such a change would constitute a 

‘‘material change’’; thus, additional 

certification testing would be required. 

(Comment 60)—One commenter 

suggested that, in proposed 

§ 1107.10(b)(2), it also should be noted 

that testing of units within a common 

family of products should allow a test 

of one unit to represent all others within 

the family of products if the other 

models are materially the same. The 

commenter added that, regarding 

proposed § 1107.10(b)(2)(ii)(B), a 

manufacturer should not be required to 

conduct additional ‘‘certification’’ 

testing upon a change to the parts or 

materials, if the change does not affect 

the overall safety of the system. The 

commenter suggested that we revise the 

section to give manufacturers the ability 

to make changes to parts and materials 

without having to undergo costly and 

time-consuming certification testing. 

The commenter would allow 

manufacturers to conduct in-house 

testing that would show that the results 

of any change do not materially alter the 

performance of that part or system with 

regard to the safety elements in the 

applicable rule. 

(Response 60)—Although regulated 

non-children’s product must still meet 

the certification requirements in section 

14(a)(1) of the CPSA, we have reserved 

subpart B, including the reasonable 

testing program described in proposed 

§ 1107.10. However, the broader issue 

presented by this commenter related to 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69509 

certification testing of units within a 

common family and when there has 

been a material change to a product is 

applicable to children’s products as 

well, so we will address this issue with 

regard to children’s products. 

The final rule does allow what the 

commenter is suggesting—that testing of 

units within a common family of 

products be allowed to represent all of 

the other units within the family. 

Section 1107.20(a) of the final rule 

states that samples used for certification 

must be identical in all material respects 

to the finished children’s product. If, as 

the commenter has stated, the tested 

units are identical in all material 

respects as others within the product 

family, then the test results can be 

applied to the other units within the 

product family. 

Section 1107.23(a) describes testing 

requirements when there has been a 

material change in a children’s product. 

If a change could adversely affect 

compliance with the applicable 

children’s product safety rules, then it is 

considered a ‘‘material change,’’ and 

retesting is required. If the commenter’s 

phrase ‘‘does not affect the overall safety 

of the system’’ means that the change 

does not affect compliance with the 

applicable rules, then the change is not 

considered a ‘‘material change,’’ and no 

recertification testing is required. 

(Comment 61)—Some commenters 

stated that the requirement to submit a 

sufficient number of samples of a 

materially changed product for third 

party testing before certifying the 

changes would be costly and would 

inhibit manufacturers from making 

continuous product improvements. 

Ultimately, according to the 

commenters, this will reduce the safety 

of children’s products. 

(Response 61)—Section 14(i)(2)(B)(i) 

of the CPSA requires children’s 

products to be subject to third party 

conformity assessment body testing 

when there has been a material change 

in the product’s design or 

manufacturing process. These types of 

changes may introduce new hazards or 

may result in the product no longer 

being in compliance with the applicable 

children’s product safety rules. After a 

material change to the product, only 

those applicable product safety rules 

that could adversely be affected require 

recertification. The samples selected 

must be of a sufficient number to 

provide a high degree of assurance that 

the test, conducted accurately, 

demonstrates the ability of the 

children’s product to meet all applicable 

children’s product safety rules. 

Regarding continuous product 

improvements, changes that do not 

adversely affect compliance to the 

applicable children’s product safety 

rules are not ‘‘material changes’’ under 

the final rule and do not require 

recertification testing. However, 

manufacturers may wish to consider 

possible material change testing as part 

of their product improvement processes. 

(Comment 62)—Three commenters 

characterized the testing requirements 

resulting from the proposed definition 

of ‘‘material change’’ as ‘‘overly 

burdensome’’ and ‘‘very unreasonable.’’ 

The commenters differed in their 

reasons for arriving at this conclusion. 

One commenter characterized the 

proposed rule’s material change testing 

requirements as too ‘‘open ended’’ 

because of imprecise language. The 

consequence of this lack of specificity, 

according to the commenter, is that 

‘‘either you will always test or you take 

a big risk. This is completely unfair and 

unreasonable.’’ 

Another commenter expressed 

concern with the examples in proposed 

§ 1107.23(c). Specifically, the 

commenter stated that manufacturing 

process changes, ‘‘such as new solvents 

to clean equipment or a new mold for 

an accessible metal component part of a 

children’s product pose undue burdens 

on manufacturers without advancing 

safety goals.’’ The commenter 

contended that ‘‘to require companies to 

develop new product specifications for 

every new solvent used in a facility or 

installation of a new mold made to the 

exact specifications as a prior mold’’ 

would require new third party testing, 

and this could not have been Congress’ 

intent. The commenter suggested: ‘‘it 

should be left to the consumer product 

manufacturer to assess whether changes 

are likely to affect the ability of the 

particular product to meet a specific 

standard, ban, rule, or regulation.’’ 

The third commenter stated that the 

proposed definition is not clear and 

asked whether ‘‘using the same quality 

level of component part but just the 

different brand is a material change.’’ 

The commenter stated that if third party 

testing of each such change is necessary, 

then ‘‘it is very unreasonable.’’ 

(Response 62)—The intent of 

§ 1107.23 for children’s products is not 

to be overly burdensome, but rather, to 

demonstrate the product’s continued 

compliance with applicable children’s 

product safety rules when a change in 

the product’s design, manufacturing 

process, or component part sourcing has 

been made that could adversely affect a 

previously certified product’s 

compliance. Because the final rule 

applies to a variety of products and 

manufacturing methods, it is 

impractical to anticipate every type of 

product change that could occur to all 

affected products that might adversely 

affect compliance to an applicable 

product safety rule and provide specific 

language. Therefore, the final rule is 

written using general language to allow 

manufacturers the flexibility to 

determine, in each particular 

circumstance, whether a product change 

could adversely affect the product’s 

compliance with an applicable 

children’s product safety rule. 

Manufacturers should use their special 

knowledge of a product’s design, 

components, and manufacturing 

processes to differentiate what changes 

may constitute a ‘‘material change,’’ and 

require certification testing, as opposed 

to nonmaterial changes. 

After initial certification of a product, 

a ‘‘material change’’ is a change that 

‘‘could affect the product’s ability to 

comply with applicable rules, standards 

or regulations.’’ The ability to adversely 

affect compliance is what distinguishes 

a ‘‘material change’’ from nonmaterial 

changes. The final rule acknowledges 

that a manufacturer has special 

knowledge of its product design, 

components and, production processes, 

and the rule states that a ‘‘manufacturer 

exercising due care knows or should 

know’’ when a change is material. For 

example, a new solvent that does not 

contain any of the prohibited chemicals 

(lead and the prohibited phthalates), or 

a replacement mold shown to be made 

to the same specifications as a 

compliant mold, would not be examples 

of ‘‘material changes.’’ 

(Comment 63)—One commenter 

noted that proposed 

§ 1107.10(b)(2)(ii)(A) would state that, 

for material changes that only affect 

product compliance to certain rules, 

certification may be based on the 

materially changed component, unless 

the change affects the finished product. 

If the change affects the finished 

product, then the certification must be 

based on the finished product. (The 

commenter is referring to proposed 

§ 1107.10(b)(2)(ii)(A) and (C).) The 

commenter asked, when a disagreement 

arises, who makes the final 

determination of whether the material 

change affects the finished product’s 

compliance? 

(Response 63)—We have reserved 

subpart B, including the reasonable 

testing program described in proposed 

§ 1107.10. However, the broader issue 

presented by this commenter relates to 

certification testing of units when there 

has been a material change is applicable 

to children’s products as well, so we 

will address this issue with regard to 

children’s products. 


emcdonald on DSK5VPTVN1PROD with RULES3
69510 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

The commenter is correct that when 

a material change to a product occurs, 

only product safety rules affected by the 

material change would require 

recertification. If the material change 

solely affects a component part of a 

children’s product and does not affect 

the ability of other component parts or 

the finished product to comply with 

applicable children’s product safety 

rules, then § 1107.23(a) allows a 

manufacturer to base certification on 

earlier third party certification tests and 

on third party testing of the changed 

component part. 

With regard to disagreements 

regarding whether the finished 

children’s product is needed for 

certification after a material change, a 

manufacturer must use due care in 

determining whether testing the 

finished product or a component part is 

required. This due care is applied on a 

per-rule basis. Some rules, such as 

prohibited phthalate content, can be 

evaluated on component parts. Other 

rules, such as the safety standard for 

cribs, always require the use of the 

finished product for certification testing. 

Assuming the disagreement is between 

the manufacturer and the CPSC 

regarding whether a finished product is 

required for certification after a product 

change, we will decide, based on the 

available evidence, whether a material 

change requires samples of the finished 

product for certification. 

b. Product Design 

Proposed § 1107.23(b) would state 

that, for purposes of subpart C, the term 

‘‘product design’’ includes all 

component parts, their composition, 

and their interaction and functionality 

when assembled. To determine which 

children’s product safety rules apply to 

a children’s product, a manufacturer 

should examine the product design for 

the children’s product as received by 

the consumer. For example, if a 

children’s product has a component part 

that contains lead or has a sharp edge, 

but is inaccessible when the product is 

assembled, then the lead and sharp edge 

requirements would not be applicable to 

the finished product. Changes to a 

product’s design may result in a product 

being subject to additional children’s 

product safety rules. For example, if a 

wooden button on a children’s product 

is replaced with a plastic button, the 

wooden button previously excluded 

from testing for lead content has been 

replaced with a component part (the 

plastic button) that would be subject to 

testing for compliance with the lead 

content requirements. 

We received no comments on this 

paragraph. However, on our own 

initiative, we have revised the second 

sentence in § 1107.23(b) to state that a 

manufacturer should examine the 

product design for the children’s 

product ‘‘as received or assembled by 

the consumer.’’ We inserted the words 

‘‘or assembled’’ because some children’s 

product safety rules require the product 

to be tested in the finished product state 

in order to assess compliance with the 

applicable children’s product safety 

rule. For example, assessing compliance 

with the inaccessibility requirements for 

the lead requirements mandates testing 

of the finished product in order to 

determine whether a component part of 

the product is accessible. The new 

language, ‘‘or assembled,’’ was added to 

make it clear to the manufacturer that 

products must be tested as received or 

assembled by the consumer in those 

instances where the product is not 

received in assembled form. 

c. Manufacturing Process 

Proposed § 1107.23(c) would state 

that a material change in the 

manufacturing process is a change in 

how the children’s product is made that 

could affect the finished children’s 

product’s ability to comply with the 

applicable children’s product safety 

rules. For each change in the 

manufacturing process, a manufacturer 

should exercise due care to determine if 

compliance to an existing applicable 

children’s product safety rule could be 

affected or if the change results in a 

newly applicable children’s product 

safety rule. The following are some 

examples of a material change to the 

manufacturing process of a children’s 

product: 

• A new technique is used to fasten 

buttons to a doll’s dress that could affect 

the children’s product’s ability to 

comply with the small parts rule; 

• New solvents are used to clean 

equipment employed in the 

manufacture of children’s products; the 

new solvents could affect the children’s 

product’s ability to comply with the 

lead content and phthalates 

requirements; and 

• A new mold for an accessible metal 

component part of a children’s product 

is introduced into the assembly line that 

could affect the children’s product’s 

ability to comply with requirements for 

sharp edges. 

We received no comments on this 

paragraph and have finalized it without 

change. 

d. Sourcing of Component Parts 

Proposed § 1107.23(d) would state 

that a material change in the sourcing of 

component parts results when the 

replacement of one component part of a 

children’s product with another 

component part could affect compliance 

with the applicable children’s product 

safety rules. This would include, but 

would not be limited to, changes in 

component part composition, 

component part supplier, or use of a 

different component part from the same 

supplier who provided the initial 

component part. 

We received no comments on this 

paragraph. However, on our own 

initiative, we have revised the first 

sentence to replace the phrase 

‘‘applicable children’s product safety 

rules’’ with ‘‘applicable children’s 

product safety rule.’’ We made this 

change to avoid creating any 

misunderstanding of whether a material 

change results only if multiple 

children’s product safety rules are 

affected; in other words, a material 

change can result, even if compliance 

with only one children’s product safety 

rule is affected. 

6. Proposed § 1107.24—Undue 

Influence 

Proposed § 1107.24(a) would 

implement the requirement to safeguard 

against undue influence, pursuant to 

section 14(i)(2)(B)(iv) of the CPSA, by 

requiring each manufacturer to establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. 

a. Procedures To Safeguard Against the 

Exercise of Undue Influence 

Proposed § 1107.24(a) would require 

the manufacturer to establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity body. 

(Comment 64)—Several commenters 

disagreed with the requirement in 

proposed § 1107.24(a) that 

manufacturers must establish 

procedures to safeguard against the 

exercise of undue influence on a third 

party conformity assessment body. One 

commenter noted that we already 

require third party conformity 

assessment bodies to train their staff to 

detect, avoid, and report undue 

influence. Another commenter stated 

that third party testing facilities already 

have these training programs in place. 

Two commenters asserted that third 

party conformity assessment bodies are 

not likely to be influenced unduly 

because their accreditation would be 

withdrawn. 

(Response 64)—Section 14(i)(2)(B)(iv) 

of the CPSA requires us to establish, by 

rule, protocols and standards for 

safeguarding against the exercise of 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69511 

undue influence by a manufacturer or 

private labeler on a third party 

conformity assessment body. This 

provision applies to manufacturers and 

private labelers as opposed to third 

party conformity assessment bodies. 

Consequently § 1107.24 of the final rule 

requires manufacturers of children’s 

products to establish procedures to 

avoid actions that could undermine the 

integrity of laboratory test data. We have 

an interest in ensuring the integrity of 

laboratory test results used in the 

certification of children’s products. 

In a separate rulemaking, we will 

address the issue of requiring third 

party conformity assessment bodies to 

report undue influence. 

(Comment 65)—Some commenters 

expressed concern regarding foreign 

manufacturers and the undue influence 

requirement. One commenter suggested 

that we will be unable to enforce the 

undue influence requirement on foreign 

manufacturers and importers. Another 

commenter said that the importer of 

record should not be responsible for 

undue influence initiated by people not 

directly employed by the importer of 

record. The commenter requested 

confirmation that importers will be 

responsible for training their employees 

only, and will not have the 

responsibility of training the employees 

of other companies, such as 

manufacturers, vendors, freight 

handlers, or laboratories. 

(Response 65)—Section 1107.24 of the 

final rule requires ‘‘each manufacturer’’ 

to establish procedures to safeguard 

against the exercise of undue influence 

by a manufacturer on a third party 

conformity assessment body. Section 

1107.2 of the final rule defines a 

‘‘manufacturer’’ as ‘‘the parties 

responsible for certification of a 

consumer product pursuant to 16 CFR 

part 1110.’’ Under 16 CFR part 1110, a 

foreign manufacturer is not required to 

certify a finished product; only a 

domestic manufacturer or the importer 

of a product made outside the United 

States is required to issue a finished 

product certificate. Thus, under 

§ 1107.24, it is a domestic manufacturer 

or the importer who must establish 

procedures to safeguard against undue 

influence. 

We agree that an importer is not 

directly responsible for training 

employees of other companies. This 

fact, however, does not absolve the 

importer issuing a finished product 

certificate of its duty to exercise due 

care when relying on test results 

provided by another company or third 

party conformity assessment body. A 

manufacturer or importer who issues a 

finished product certificate that is based 

on test reports from a third party 

conformity assessment body over whom 

undue influence has been exercised 

provides a basis for the CPSC to deem 

the certificate invalid. We will hold the 

finished product certifier responsible for 

exercising due care that component part 

or finished product manufacturers or 

suppliers have not exercised undue 

influence over third party conformity 

assessment bodies. 

(Comment 66)—Two commenters 

stated that because the term ‘‘undue’’ is 

undefined, nothing should be construed 

to prohibit a manufacturer from 

exercising its rights to challenge third 

party conformity assessment body test 

results based upon the manufacturer’s 

belief that they are inaccurate. 

(Response 66)—Section 1107.24 is not 

intended to preclude a manufacturer 

from challenging failing test results in 

appropriate circumstances. If a 

manufacturer has reason to think a test 

result received from a third party 

conformity assessment body is in error, 

it is appropriate to ask the third party 

conformity assessment body about the 

test result. Such inquiry does not 

constitute undue influence. 

Additionally, § 1107.20(d) requires a 

manufacturer to investigate the reasons 

for a negative certification test result 

and to take action to address failing test 

results before a Children’s Product 

Certificate can be issued. This 

investigation may involve discussions 

about the test results with the third 

party conformity assessment body. 

b. Minimum Requirements 

Proposed § 1107.24(b) would require 

the procedures described in § 1107.24(a) 

to include minimal requirements. 

Proposed § 1107.24(b)(1) would require 

safeguards to prevent attempts by the 

manufacturer to exercise undue 

influence on a third party conformity 

assessment body, including a written 

policy statement from company officials 

that the exercise of undue influence is 

not acceptable, and directing that 

appropriate staff receive annual training 

on avoiding undue influence and sign a 

statement attesting to participation in 

such training. Proposed § 1107.24(b)(2) 

would impose a requirement to notify 

the Commission immediately of any 

attempt by the manufacturer to hide or 

exert undue influence over test results. 

Proposed § 1107.24(b)(3) would impose 

a requirement to inform employees that 

allegations of undue influence may be 

reported confidentially to the 

Commission and describe to employees 

the manner in which such a report can 

be made. 

(Comment 67)—Several commenters 

made remarks about training programs. 

Two commenters stated that the training 

program and recordkeeping 

requirements (proposed § 1107.26(a)(5)) 

are burdensome and redundant because 

companies already have requirements to 

prohibit unethical behavior, such as 

exerting undue influence over third 

party conformity assessment body staff. 

Other commenters described this 

requirement as excessive and 

unreasonable. One commenter stated 

that the requirements for training are 

vague and urged us to describe what 

needs to be included. Another 

commenter raised questions about the 

content and form of the training, 

especially whether a written manual 

would be enough. Another commenter 

recommended deleting these 

requirements. 

One commenter urged us to delete the 

requirement for appropriate staff to 

receive ‘‘annual training’’ on how to 

avoid undue influence. The commenter 

felt that an annual training mandate 

would be unnecessary and impose 

excessive costs and burdens on 

manufacturers of children’s products. 

(Response 67)—Section 14(i)(2)(B)(iv) 

of the CPSA requires us to establish 

protocols and standards, by rule, for 

safeguarding against the exercise of 

undue influence on third party 

conformity assessment bodies by a 

manufacturer or private labeler. 

Therefore, we decline the suggestion to 

delete these requirements from the final 

rule. 

Section 1107.24 of the final rule 

implements the statutory mandate by 

requiring manufacturers to establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. The rule 

does not prescribe the form or content 

of these programs in order to provide 

manufacturers flexibility in 

implementing the requirements. For 

example, manufacturers may wish to 

create written manuals and may include 

this training along with other forms of 

employee training. Manufacturers must 

keep records of employee participation 

in the training to be able to ensure that 

all relevant staff members receive this 

training pursuant to § 1107.26(a)(6). 

We do agree, however, with the 

commenter who suggested that an 

annual training requirement reiterating 

previously presented procedures can 

impose costs and burdens the benefits of 

which are unclear. Thus, we have 

replaced the proposed requirement for 

annual training with a requirement for 

retraining when a substantive change to 

the rule is made regarding undue 

influence; this requirement appears as a 

new § 1107.24(b)(2), and we have 


emcdonald on DSK5VPTVN1PROD with RULES3
69512 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

renumbered proposed §§ 1107.24(b)(2) 

and 1107.24(b)(3) as §§ 1107.24(b)(3) 

and 1107.24(b)(4), respectively, in the 

final rule. Manufacturers of children’s 

products are free to modify their 

procedures and conduct retraining as 

often as they feel it is necessary to 

institute effectively their policies for 

safeguarding against the exercise of 

undue influence. 

Additionally, on our own initiative, 

we have revised § 1107.24(b) of the final 

rule to make minor editorial or 

grammatical changes. We have revised 

§ 1107.24(b)(1) to direct that ‘‘every 

appropriate staff member’’ receive 

training on how to avoid undue 

influence. The proposal would state that 

‘‘appropriate staff receive annual 

training.’’ By referring to ‘‘every 

appropriate staff member,’’ the final rule 

clarifies that the emphasis is on training 

individuals rather than collections of 

individuals. Additionally, in 

§ 1107.24(b(4), we have replaced 

‘‘Commission’’ with ‘‘CPSC’’ and 

replaced ‘‘to describe the manner’’ with 

‘‘a description of the manner.’’ 

7. Proposed § 1107.25 Remedial 

Action 

Proposed § 1107.25 would require 

each manufacturer of a children’s 

product to have a remedial action plan 

that contains procedures that the 

manufacturer must follow to investigate 

and address failing test results. 

(Comment 68)—One commenter 

stated that requiring each manufacturer 

to have an actual remedial action plan 

to address failing test results is 

unnecessary because the remedial 

action will likely be different, 

depending upon the situation. Another 

commenter stated that because they are 

familiar with how to resolve compliance 

and quality issues, the preparation of a 

detailed written remedial action plan is 

a waste of time, money, resources, and 

intellect. 

(Response 68)—The commenter is 

correct that, depending on the product 

and the nature of the test failure, 

remedial actions may take many 

different forms. The development of a 

remedial action plan before production 

commences could help in the 

determination of factors, such as lot size 

or what tracking information to 

maintain. These factors could help limit 

the number of production units subject 

to recall in the event that noncompliant 

products are introduced into commerce. 

However, although it may be efficient 

and useful to have a formal process 

(such as the remedial action plan in 

proposed § 1107.25) to follow after 

receiving failing test reports, such 

preformulated plans are not essential, 

either for certification or for ensuring 

continued compliance of consumer 

products. Ultimately, the manufacturer 

is responsible for ensuring that the 

product that they make complies with 

the applicable product safety rules. For 

some products and types of failing test 

reports, ad hoc methods may be as 

effective as preestablished plans in 

addressing the test failures and ensuring 

that products are compliant. For these 

reasons, we have removed the 

requirements for remedial action plans 

for children’s products from the final 

rule. We encourage manufacturers who 

believe that remedial action plans 

would be advantageous for their product 

to develop such plans as part of their 

overall quality assurance system. 

(Comment 69)—One commenter 

appreciated the acknowledgement that a 

remedial action plan could be a formal 

standard operating procedure (SOP), 

along with recordkeeping of each event. 

The commenter asked whether, when a 

particular component causes a product 

to become noncompliant with a rule, 

and the remedial action eliminates this 

specific component from the product, 

would certification have to be repeated. 

The commenter noted that 

documentation would be provided that 

the noncompliant component had been 

removed and that the product 

specification was revised. The 

commenter stated that there would be 

an SOP that requires a corrective action, 

along with documentation of the 

instance of noncompliance, to provide 

evidence that the product has been 

corrected and is compliant. 

(Response 69)—As noted in our 

response to Comment 68, we have 

removed the requirement for a remedial 

action plan for children’s products from 

the final rule. If a finished product has 

a noncompliant component part (such 

as an accessory item), and that item is 

removed from the finished product, the 

finished product certifier does not have 

to repeat certification testing on the 

newly constituted finished product 

because the certifier has certification 

test data demonstrating compliance 

with all applicable product safety rules 

for that product. The certifier should 

make sure that eliminating the 

noncompliant component part does not 

affect compliance with another 

applicable children’s product safety rule 

for the finished product. 

(Comment 70)—Several comments 

addressed the issue of retesting samples. 

Some commenters noted that often, a 

testing failure might result from a faulty 

laboratory test and not from a 

noncompliant product. The commenters 

said that the rule should allow retesting 

in appropriate situations when there is 

suspicion about the manner in which a 

sample was handled or processed, or the 

certifier is challenging the results of a 

third party test. 

One commenter asserted that if the 

manufacturer documents and supports 

any assertions related to the faulty test 

and the product’s compliance, there 

should be no need for remedial action. 

Another commenter suggested that the 

implication in the rule is that any test 

failure, no matter how trivial, would 

trigger the need for remedial action, 

which would be costly. The commenter 

suggested that establishing tolerances 

for test results is necessary to reduce 

testing costs, as well as the burden of 

remedial actions, and at the same time 

ensure product safety. The commenter 

added that children’s products are not 

so consistent that every test produces 

the same test result. The commenter 

asserted that retesting is a valid means 

of responding to a failing test result. 

Banning retesting out of fear that some 

unscrupulous parties will attempt to test 

the product into compliance will create 

severe problems. 

(Response 70)—We have removed the 

requirement for a remedial action plan 

for children’s products from the final 

rule. However, we recognize that an 

error or failure in the testing of a sample 

may lead to a failing test result, and 

therefore, investigating the test method 

and test execution is a legitimate avenue 

of investigation in those instances. Such 

an investigation can include examining 

the test procedures, sample preparation 

steps, equipment calibration, and other 

factors, in addition to tests on samples 

of the product as part of the 

investigation, which may affect test 

results, but are not indicative of a 

noncompliant product. Additionally, 

§ 1107.20(d) of the final rule states that 

if a product sample fails certification 

testing to the applicable children’s 

product safety rule(s), even if other 

samples have passed the same 

certification test, the manufacturer must 

investigate the reasons for the failure 

and take the necessary steps to address 

the reasons for the failure. A 

manufacturer cannot certify the 

children’s product until the 

manufacturer establishes, with a high 

degree of assurance that the finished 

product does comply with all applicable 

children’s product safety rules. While 

the final rule no longer refers to 

remedial action plans, a manufacture 

still ‘‘must investigate the reasons for 

the failure and take the necessary steps 

to address the reasons for the failure.’’ 

Retesting a product without 

investigating why the test yielded 

failing results, and taking whatever 

action addresses the situation (for 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69513 

example, calibrating the testing machine 

before retesting, or correcting a 

manufacturing problem) to achieve 

passing results, is not acceptable for 

certification purposes because the 

certifier would not have a high degree 

of assurance that the products produced 

will be compliant with the applicable 

product safety rules. 

Retesting should not be conducted to 

‘‘shop’’ for passing test results or to keep 

testing the product until a sample 

finally passes (and disregarding all other 

tests that suggest the product is not in 

compliance). 

With regard to establishing tolerances 

for test results, the acceptable values for 

test results are established in each rule, 

ban, regulation, or standard and are 

beyond the scope of this rule. 

(Comment 71)—One commenter 

stated that some standards, such as the 

standard for the surface flammability of 

carpets and rugs (16 CFR part 1630), 

have alternative requirements for 

products that fail tests. The commenter 

suggested modifying the language to 

refer to a product that does not pass the 

applicable product safety standard, 

rather than a product that ‘‘fails’’ a test. 

(Response 71)—In 16 CFR part 1630, 

the standard allows for a single failure 

in eight tests. Because there is an 

allowance in the standard for a failing 

test result, we would view such a 

product as compliant with the standard. 

8. Proposed § 1107.26 Recordkeeping 

a. The Records To Be Kept 

Proposed § 1107.26(a) would require a 

children’s product manufacturer to 

maintain records pertaining to: 

• The Children’s Product Certificate 

for each product (proposed 

§ 1107.26(a)(1)); 

• Each third party certification test 

(proposed § 1107.26(a)(2)); 

• The periodic test plan and periodic 

test results (proposed § 1107.26(a)(3)); 

• Descriptions of all material changes 

in product design, manufacturing 

process, and sourcing of component 

parts, and the certification tests run and 

the test values (proposed 

§ 1107.26(a)(4)); 

• Undue influence procedures 

(proposed § 1107.26(a)(5)); and 

• All remedial actions taken 

following a failing test result (proposed 

§ 1107.26(a)(6)). 

We did not receive any comments 

directly addressing proposed 

§ 1107.26(a). However, on our own 

initiative, or to complement other 

changes in the final rule, we have 

revised § 1107.26(a) as follows: 

• In § 1107.26(a)(1), we have changed 

‘‘Records of the children’s product 

certificate’’ to ‘‘A copy of the Children’s 

Product Certificate.’’ This change is 

intended to simplify the language in the 

codified text and use a consistent style 

throughout part 1107 when referring to 

the Children’s Product Certificate. 

• We have finalized § 1107.26(a)(2) 

without change. 

• In § 1107.26(a)(3), we have revised 

the recordkeeping elements to reflect 

changes to the periodic testing provision 

at § 1107.21. Thus, the final rule 

requires records of: (1) The periodic test 

plan and periodic test results; (2) a 

production testing plan, production test 

results, and periodic test results; or (3) 

testing results of tests conducted by a 

testing laboratory accredited to ISO/IEC 

17025:2005 and periodic test results. 

• We have reserved § 1107.26(a)(4). 

We intend to place any recordkeeping 

requirement associated with the testing 

of ‘‘representative samples’’ at 

§ 1107.26(a)(4). As we stated earlier in 

part III.D.4 of this document, the final 

rule removes § 1107.22 because H.R. 

2715 amended the CPSA to change 

‘‘random samples’’ to ‘‘representative 

samples.’’ 

• We have renumbered proposed 

§ 1107.26(a)(4) as § 1107.26(a)(5), and 

we have finalized it without change. 

• We have renumbered proposed 

§ 1107.26(a)(5) as § 1107.26(a)(6), and 

we have finalized it with one change to 

clarify that manufacturers must retain 

copies of the attestations required under 

§ 1107.24(b)(1). 

• We have deleted proposed 

§ 1107.26(a)(6), which would pertain to 

records of all remedial actions. We have 

deleted this provision from the 

recordkeeping requirements because the 

final rule does not establish remedial 

action requirements for children’s 

products. 

b. The Location Where Records Are To 

Be Kept, the Recordkeeping Period, and 

the Records’ Availability in the English 

Language 

Proposed § 1107.26(b) would require a 

manufacturer to maintain the records 

specified in subpart C at the location 

within the United States set forth in 16 

CFR 1110.11(d) or, if the records are not 

maintained at the custodian’s address, 

at a location within the United States 

specified by the custodian. The 

manufacturer would be required to 

make these records available, either in 

hard copy or electronically, for 

inspection by the CPSC, upon request. 

Proposed § 1107.26(c) also would 

require a manufacturer to maintain 

records (except for test records) for as 

long as the product is in production or 

imported by the manufacturer, plus five 

years. Test records would be required to 

be maintained for five years. All records 

would be required to be available in the 

English language. 

(Comment 72)—One commenter 

expressed concern about the 

recordkeeping requirements in proposed 

§ 1107.10(b)(5) and asked for 

clarification of the phrase ‘‘for as long 

as the product is in production or 

imported.’’ The commenter noted that 

the requirements would lead to a 

massive undertaking for any 

manufacturer or importer, especially if 

all of the records must be maintained 

within the United States. 

Another commenter stated that we 

should clarify the relationship between 

the requirement to maintain records and 

the proposed rule’s treatment of 

material changes requiring 

recertification, and thus, effectively 

creating a new product. To simplify the 

recordkeeping requirements, the 

commenter asked that the recordkeeping 

requirements apply ‘‘for as long as the 

product, without a material change, is 

in production or imported by the 

manufacturer plus five years’’ (emphasis 

in original). Otherwise, the commenter 

stated, manufacturers of long-running 

products would have to maintain 

records in perpetuity, which would 

increase costs without assisting safety or 

compliance. 

(Response 72)—Although the final 

rule reserves subpart B (which includes 

proposed § 1107.10(b)(5)), the issues 

raised by the commenters are applicable 

to the recordkeeping requirement for 

children’s products, so we address this 

issue here for children’s products. 

We agree that the burden of 

maintaining records for the life of a 

product, plus five years, could be 

unduly burdensome and difficult to 

implement, in cases where products 

undergo changes over time. Moreover, 

having a different time period for the 

retention of test reports versus other 

records may be confusing. Accordingly, 

we have revised the recordkeeping 

provision, such that all records must be 

maintained for at least five years from 

the date of their creation. If a product 

does not comply with an applicable 

children’s product safety rule in a 

significant way, it is likely that the 

noncompliant aspect of the product 

would become apparent within the 5- 

year period. This change should result 

in less confusion for the regulated 

community regarding how long records 

for a particular product must be 

maintained. 

Additionally, on our own initiative, 

we have reorganized proposed 

§ 1107.26(b) and (c), by combining them 

into § 1107.26(b) of the final rule. We 


emcdonald on DSK5VPTVN1PROD with RULES3
69514 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

describe other changes in § 1107.26 

immediately below. 

(Comment 73)—Several commenters 

expressed concern about the 

requirement that records be maintained 

in English. Some commenters stated 

that we should allow records to be kept 

in the local language and only require 

translation into English by the 

manufacturer or importer when we 

request documentation. One commenter 

noted that the proposed rule will 

require millions of test reports and 

records to be created and maintained in 

English, even though only a small 

fraction of a percent of these test reports 

will ever be reviewed by the CPSC or 

other third parties. The commenter 

maintained that this would be very 

expensive for the manufacturer because 

they must find and hire Englishspeaking technicians to perform the 

testing. 

The commenter also contended that 

this requirement could be potentially 

hazardous. The commenter posed this 

example: 

For example, a quality assurance 

technician in Vietnam may be excellent at 

maintaining the quality of a product, and she 

may even have a passable grasp of English, 

but her English skills may not be sufficient 

to communicate precise technical findings in 

English. If she is nonetheless required to 

record her findings in English, then there is 

a risk the test results will be transcribed, 

described and maintained inaccurately. 

Thus, we ask that the Commission reconsider 

this English-only requirement in the 

proposed rule. 

Another commenter asserted that a 

method for making documents available 

in English in the United States would 

need to be created to comply with the 

rule. The commenter contended that the 

requirement to have English language 

documents available within the United 

States does not offer additional 

confidence in product safety for U.S. 

consumers. Alternatively, the 

commenter suggested that a 3-year stay 

of the requirement that documents be 

maintained in English would allow a 

transition period to establish and 

implement appropriate infrastructure 

and processes for expanded 

recordkeeping. 

(Response 73)—We agree that it 

would be burdensome in many cases for 

all records to be maintained in English. 

Therefore, § 1107.26(b) in the final rule 

allows records to be maintained in 

languages other than English, if the 

records in the original language can be 

provided immediately by the 

manufacturer to the CPSC, and if an 

accurate English translation can be 

provided within 48 hours, or within 

such longer period of time, as may be 

negotiated with CPSC staff. Given this 

change to the final rule, we decline to 

adopt the suggestion that a 3-year stay 

of enforcement be implemented for this 

part of the rule. 

(Comment 74)—Many commenters 

expressed concern about the 

requirement in proposed § 1107.26(b) 

that all records be maintained in the 

United States. Several commenters 

suggested that instead of requiring 

manufacturers to maintain records at a 

location within the United States, we 

should allow the records to be 

maintained outside the United States, so 

long as the records can be accessed from 

a location within the United States that 

is specified on the certificate. Some 

commenters noted that this requirement 

would be a burdensome and massive 

undertaking. One commenter did not 

believe that storing foreign 

manufacturing documents in the United 

States for every regulated product 

increases product safety. The 

commenter noted that these documents 

could be stored in their existing location 

and be submitted to the CPSC, upon 

request. Alternatively, the commenter 

suggested that a 3-year stay of the 

requirement that documents be 

maintained in the United States would 

allow a transition period to establish 

and implement appropriate 

infrastructure and processes for 

expanded recordkeeping. 

Another commenter noted that ISO 

9001, Quality management systems— 

Requirements, requires manufacturers to 

maintain these types of records at the 

factory where a product subject to 

certification is manufactured. Rather 

than requiring foreign manufacturers to 

maintain duplicate records in the 

United States, the commenter suggested 

that the final rule should harmonize 

CPSC requirements with ISO’s, and 

require records to be made available to 

us for inspection, either in hard copy or 

electronically, through the U.S. 

subsidiary or other U.S. corporate 

entity, within a reasonable time after the 

CPSC requests them, pursuant to section 

16(b) of the Consumer Product Safety 

Act. 

(Response 74)—We agree that it may 

be burdensome and duplicative in many 

cases to maintain all records in the 

United States. To reduce this burden 

and still maintain prompt access to 

records when needed, § 1107.26(b) of 

the final rule no longer requires records 

to be maintained in the United States. 

However, all records must be made 

available, either in hard copy or 

electronically, such as through an 

Internet Web site, for inspection by the 

CPSC, upon request. Because the change 

eliminates the requirement that records 

be kept in the United States, we decline 

to adopt the suggestion of a 3-year stay 

of enforcement of this part of the rule. 

Regarding harmonization with the 

requirements of ISO 9001, the 

commenter did not specify which 

requirements in ISO 9001 should be 

harmonized. However, eliminating the 

requirement that records be maintained 

at a location within the United States 

would be consistent with sections 

4.2.3.d of ISO 9001 (to ensure that 

relevant versions of applicable 

documents are available at points of 

use), and section 4.2.3.g of ISO 9001 (to 

prevent the unintended use of obsolete 

documents, and to apply suitable 

identification to them if they are 

retained for any purpose). 

(Comment 75)—One commenter 

stated that some of the required 

recordkeeping is ‘‘redundant and 

unnecessarily duplicative,’’ such as 

production testing plans for multiple 

factories. Fees for outsourcing these 

services could be significant and 

burdensome to many small businesses, 

the commenter asserted. 

(Response 75)—Section 1107.21(c)(2) 

of the final rule sets forth the option to 

implement a production testing plan to 

increase the maximum periodic test 

interval, and § 1107.21(c)(2)(ii) of the 

final rule requires that each 

manufacturing site conduct separate 

production testing because the location 

at which a product is manufactured 

could have a material effect on the 

product’s ability to comply with the 

applicable rules. Factors such as power 

quality, climate, personnel, and factory 

equipment could materially affect the 

manufacture of a product. Because it 

cannot be assumed that units of the 

same product manufactured in more 

than one location are identical in all 

material respects, the finished product 

certifier must conduct separate 

production testing for the product for 

each manufacturing site. We have taken 

other steps to reduce the recordkeeping 

burden, such as not requiring that 

records be kept in the United States, and 

we are eliminating the requirement that 

all records must be maintained in 

English. 

(Comment 76)—One commenter 

noted that companies have established 

processes and formats and, in many 

cases, invested in information 

technology solutions to prepare and 

transmit these certificates in accordance 

with the law. The commenter added: 

‘‘Retailers are relying upon such 

certificates as they can with the benefit 

of reduced liability under section 19 of 

the CPSA’’ as evidence that the products 

comply with all the applicable product 

safety rules. The commenter stated that 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69515 

we need to clarify that the form of 

delivery of title, in and of itself, should 

not require additional testing, 

documentation, and certification. The 

commenter also asked us to clarify that 

retailers can rely upon domestically 

located supplier certifications without 

duplication of testing and certification 

requirements. 

(Response 76)—A certificate must 

accompany the product, as specified in 

16 CFR part 1110. Certificates can be in 

paper or electronic form, as described 

by the commenter. The commenter is 

correct that the issuance of a Children’s 

Product Certificate means that the 

children’s product has passed its 

certification tests. If the commenter is 

referring to additional third party tests 

requested by retailers after the issuance 

of a certificate, we emphasize, as we did 

in the preamble to the proposed rule, 

that retailers and sellers of children’s 

products can rely on certificates 

provided by product certifiers without 

having to conduct additional testing, if 

those certificates are based on testing 

conducted by a CPSC-accepted third 

party conformity assessment body. 

(Comment 77)—One commenter 

stated that the proposed recordkeeping 

requirements will have the largest 

immediate impact to the retail industry. 

The commenter stated that to meet these 

provisions, a process to centrally 

maintain records for an estimated 

300,000 items per year would need to be 

created. The number of pages of 

documentation covering a portion of 

products for one large general 

merchandise retailer acting as importer 

of record, would range from a low of 

375,000,000 pages to more than 

1,000,000,000 pages per year. The 

commenter’s estimate was based upon 

the following: 

• Full product specification (150–200 

pages); 

• Certification testing (30–100 pages); 

• Production testing plan (inspection 

records, testing documents, and 

production plans quality control 

documents) (1,000–3,000 pages); and 

• Periodic testing (50–200 pages). 

This estimate did not include records 

of remedial action, if necessary. 

Another commenter stated that the 

standards of recordkeeping outlined in 

the proposed rule are clear and should 

not present an unreasonable burden on 

manufacturers or importers. The 

commenter asserted that any 

responsible firm would maintain these 

records even without the rule, and they 

further asserted that establishing a 

reasonable baseline for product safety 

recordkeeping is crucial to enforcement. 

(Response 77)—We have revised the 

final rule to reduce costs associated 

with recordkeeping requirements, such 

as reducing and simplifying the record 

retention period to five years from the 

date of creation for all records, 

eliminating the requirement that records 

must be maintained in English, and 

eliminating the requirement that records 

must be maintained in the United 

States. Moreover, removal of the 

remedial action plan requirement for 

children’s products should further 

reduce the recordkeeping burden for 

manufacturers. 

Even with these changes, the burden 

associated with the rule’s recordkeeping 

requirements will vary among 

manufacturers or importers. As the 

commenters indicate, some 

manufacturers will consider the burden 

to be significant, whereas others will 

feel that the recordkeeping requirements 

are comparable to those at ‘‘any 

responsible firm.’’ The recordkeeping 

burden could be fairly heavy for some 

products and relatively light for others, 

depending upon the complexity of the 

product, the number of product safety 

rules that are applicable to the product, 

and the amount of testing required. 

However, as stated in the preamble to 

the proposed rule (75 FR at 28360), 

documentation and recordkeeping are 

required to establish the identity of the 

product and to demonstrate that the 

product complies with the applicable 

safety rules, not only when it is 

certified, but also on a continuing basis 

after certification. 

The final rule gives manufacturers 

and importers the flexibility to maintain 

records. The final rule does not require 

that the records be maintained in a 

specific CPSC format. While the final 

rule specifies what records or 

information must be maintained, a 

manufacturer may maintain the 

records—as the commenter suggested— 

within their own recordkeeping 

systems, if those systems meet the 

traceability requirements and ensure 

that products are certified properly 

before they enter into commerce. 

(Comment 78)—One commenter 

stated that manufacturers of children’s 

furniture cannot provide any data on the 

cost of the recordkeeping requirements 

because they do not know yet the 

storage capacity that will be required to 

comply with the rule. Furniture 

manufacturers of non-children’s 

products have reported that the cost of 

creating the system to collect their data 

on 16 CFR part 1303 compliance was 

approximately $100,000, and the cost of 

records maintenance was in the range of 

$30,000 to $50,000 per year. Based on 

this, furniture manufacturers of 

children’s products are certain that it 

will cost them in excess of $100,000 to 

build and program such a system. These 

furniture companies will require 

additional staff to maintain and update 

the system, and that will require the 

expenditure of at least $30,000 to 

$50,000 a year, per person. 

(Response 78)—We acknowledge that 

there will be costs for tracking the data 

and maintaining the records, which 

could involve the development of 

software for tracking and managing the 

data and hiring additional staff. 

However, the final rule’s recordkeeping 

requirements give manufacturers 

flexibility in determining how to meet 

them. Further, we have revised the final 

rule to reduce costs associated with 

recordkeeping requirements, such as 

reducing and simplifying the record 

retention period to five years from the 

date of creation for all records, 

eliminating the requirement that records 

must be maintained in English, and 

eliminating the requirement that records 

must be maintained in the United 

States. 

(Comment 79)—One commenter 

stated that as long as the manufacturer 

can use existing documentation, then 

there should not be an undue burden on 

the regulated community to comply 

with third party testing requirements for 

children’s products. However, the 

commenter noted that if we intend to 

require that the manufacturer maintain 

documentation in a different format, 

then there will be a cost associated with 

maintaining this information. 

(Response 79)—The final rule does 

not require manufacturers to develop 

codes, numbering systems, or special 

data formats. A manufacturer is free to 

use any format, provided that the 

required information is available to the 

CPSC, when requested. 

(Comment 80)—One commenter 

objected to the requirement that records 

must be maintained for five years. The 

commenter pointed out that the larger 

suppliers to the U.S. market, including 

chain stores, divide an order and ship 

separately to different states. Without 

giving details, the commenter implied 

that this would make the requirement to 

keep all required records for five years 

a heavy burden on manufacturers. 

(Response 80)—This comment is from 

a trade association for a foreign 

manufacturer of children’s products that 

may have misinterpreted the proposed 

rule. The proposed rule would require 

test records to be maintained for five 

years; other records would be 

maintained for as long as the product 

was in production or imported (without 

a material change), plus five years. In 

any event, a foreign manufacturer has 

no obligation to keep the records 

specified under § 1107.26, unless it 


emcdonald on DSK5VPTVN1PROD with RULES3
69516 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

agrees contractually to maintain the 

records on behalf of the importer. Even 

under these circumstances, only the 

importer has the obligation to keep the 

records. The importer, as the certifier, is 

responsible for maintaining the records 

or having another party maintain the 

records on its behalf. As for the retailer 

in the distribution chain, they are not 

required to keep the records unless they 

are also the importer. An importer’s 

obligation to maintain the records for 

the product is independent of how 

many different retailers distribute the 

product. Regarding the burden of 

keeping records for five years, the 5-year 

record retention requirement was 

selected to be consistent with the 5-year 

statute of limitations in 28 U.S.C. 2462. 

However, this requirement is not 

intended to supersede record retention 

times that are specified in existing 

regulations. 

E. Proposed Subpart D—Consumer 

Product Labeling Program 

1. Introduction 

Proposed subpart D, consisting of one 

section, would implement the label 

provision at section 14(i)(2)(A) of the 

CPSA. Section 14(i)(2)(A) of the CPSA 

requires the Commission to initiate a 

program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements in section 

14(a) of the CPSA. 

2. General Requirements 

Proposed § 1107.40(a) would allow 

manufacturers and private labelers of a 

consumer product to indicate, by a 

uniform label on or provided with the 

product, that the product complies with 

any consumer product safety rule under 

the CPSA, or with any similar rule, ban, 

standard or regulation under any other 

act enforced by the CPSC. 

(Comment 81)—One commenter 

contended that allowing manufacturers 

to place an optional label on their 

products that states: ‘‘Meets CPSC 

Safety Requirements,’’ could give 

manufacturers who use such a label an 

unfair market advantage over 

manufacturers who choose not to 

include the label. The commenter stated 

that some manufacturers will not use 

the label because it will increase their 

product’s cost. The commenter 

suggested that some consumers may 

choose the labeled product based upon 

a false assumption that a product 

without the label is somehow less safe. 

The commenter stated that some 

manufacturers will use the label as a 

misleading marketing tool or even alter 

the font type or size of the label for 

marketing purposes. 

(Response 81)—Section 14(i)(2)(A) of 

the CPSA requires us to initiate a 

program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements of section 

14(a) of the CPSA. Section 1107.30 of 

the final rule (formerly proposed 

§ 1107.40) implements this requirement. 

Use of the labeling program is at the 

discretion of the manufacturer or private 

labeler, and the manufacturer or private 

labeler must determine costs versus 

benefits for their particular products. 

The label specifications are designed to 

avoid giving consumers the false 

impression that the product is CPSCtested, -approved, or -endorsed. Section 

1107.30(d) of the final rule prohibits 

manufacturers or private labelers from 

implying, through manipulation of the 

font type, font size, or other means that 

the CPSC has tested, approved, or 

endorsed the product. 

Other than renumbering this section, 

we have finalized paragraph (a) without 

change. 

3. Label Specifications 

Proposed § 1107.40(b) would require 

the label to be printed in bold typeface, 

using an Arial font of not less than 12 

points, be visible and legible, and state: 

‘‘Meets CPSC Safety Requirements.’’ 

(Comment 82)—One commenter 

stated that the final rule should not 

specify the features that must be used 

for the optional label indicating that a 

product meets the CPSC’s safety 

requirements. The commenter did not 

think we should specify features such as 

size, color, font, or location because 

these will depend on the product. The 

commenter noted that there is the 

possibility that the specified text type 

and size will not be compatible with the 

different internal systems developed by 

retailers and manufacturers to meet the 

needs of the affected product. The 

commenter said that to specify any 

requirements other than what works 

with a firm’s internal systems would 

have absolutely no benefit at all. 

Another commenter expressed 

concern with the font size being ‘‘no 

less than 12 points’’ because that could 

be a problem on some small containers. 

The commenter said that we should use 

instead, the font size requirements in 

the Federal Hazardous Substances Act. 

One commenter agreed with our 

approach of labeling products to 

indicate compliance with the rules. The 

commenter recommended that the 

CPSC’s labeling program include 

guidelines for the type, style, color, and 

font of such labels and should consider 

use of symbols or a mark, rather than 

words or initials, as proposed. Symbols 

also would help overcome language 

barriers for communicating compliance. 

The commenter said that the guidelines 

should allow variations in the label’s 

size to accommodate products of 

different physical dimensions, but the 

general appearance of the label must 

remain consistent. They recommended 

that the labels appear as a permanent 

mark on the product packaging, as well 

as on the product itself. 

(Response 82)—We agree with the 

commenters that specifying particular 

fonts and minimum sizes for the label 

could make adding a label difficult for 

some products. Depending on the 

product’s characteristics, such as size, 

surface finish, and the presence of a 

smooth, flat area for the label, a label 

with a minimum font size may be 

difficult to apply. Therefore, 

§ 1107.30(b) of the final rule 

(renumbered from proposed 

§ 1107.40(b)) specifies that the label 

must be visible and legible and does not 

specify a font and a minimum size. This 

change will give manufacturers the 

flexibility to implement a labeling 

system tailored to their product. 

The text of the message on the label 

remains: ‘‘Meets CPSC Safety 

Requirements.’’ The label may be 

affixed to the product or provided with 

the product to provide flexibility for the 

manufacturer or private labeler in their 

implementation of the labeling 

requirements. Because the labeling 

requirements will apply to all consumer 

products covered by an applicable 

product safety rule, it would be 

impossible to design a label that would 

work with every firm’s internal system. 

Regarding the labeling requirements 

in the Federal Hazardous Substances 

Act (FHSA), the commenter did not 

specify which labeling requirements 

should be used. The general labeling 

requirements for labeling certain toys 

and games in section 24(d) of the FHSA 

states that the label shall be displayed 

in the English language in conspicuous 

and legible type in contrast by 

typography, layout, or color with other 

printed matter. The changes to the final 

rule are consistent with the FHSA in 

this regard. 

The final rule does not allow for the 

use of a symbol or mark because a 

symbol or mark might be misinterpreted 

as a CPSC certification mark or CPSC 

endorsement of the product. 

Additionally, the recommendation that 

a label be affixed to the product and its 

packaging may reduce the flexibility of 

manufacturers who choose to use the 

labeling program. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69517 

In reviewing the comments submitted 

regarding labels and the provisions of 

subpart D of the proposed rule, we 

noticed that proposed § 1107.40(d) 

(renumbered as § 1107.30(d) in the final 

rule) could be misunderstood to imply 

that an alternative label may be used in 

place of the label specified in proposed 

§ 1107.40(b). We have revised 

§ 1107.30(d) in the final rule to state that 

other labels, in addition to the label 

specified in § 1107.30(b), may be placed 

on the product, as long as the additional 

labels do not change the meaning of the 

label specified in § 1107.30(b). 

(Comment 83)—One commenter 

argued that the requirement to provide 

only the statement: ‘‘Meets CPSC Safety 

Requirements,’’ is not adequate for 

indicating compliance. The commenter 

asserted that a registered certification 

mark is the only way to indicate 

adequately full compliance, and they 

noted further that the use of a registered 

certification mark is also used as a tool 

to address counterfeiting activities. 

(Response 83)—The consumer 

product labeling program described in 

proposed § 1107.40 (renumbered as 

§ 1107.30 in the final rule) is voluntary 

on the part of a manufacturer, importer, 

or private labeler. Section 14(a) of the 

CPSA requires the manufacturer, 

importer, and private labeler to issue a 

General Conformity Certificate or a 

Children’s Product Certificate for any 

product covered by an applicable 

product safety rule, regardless of 

whether a manufacturer elects to label 

their product under § 1107.30. A 

registered certification mark authorized 

by a certification body for a 

manufacturer to include with the 

product does not contain the 

information required by a certificate, as 

specified in 16 CFR part 1110, and it 

cannot be used in place of the 

certificate. Thus, we disagree with the 

commenter that certification marks are 

the only way to indicate full 

compliance. Other products, such as 

mattress sets, indicate compliance (in 

this case to 16 CFR part 1633) without 

the use of certification marks. 

Furthermore, we are aware of multiple 

instances of counterfeit certification 

marks on consumer products. As a 

result, we decline to revise the rule as 

suggested by the commenter. 

4. Conditions Under Which a Consumer 

Product May Bear the Label 

Proposed § 1107.40(c) would allow a 

consumer product to bear the label if the 

manufacturer or private labeler has 

certified, pursuant to section 14 of the 

CPSA, that the consumer product 

complies with all applicable consumer 

product safety rules under the CPSA 

and with all rules, bans, standards, or 

regulations applicable to the product 

under any other act enforced by the 

Consumer Product Safety Commission. 

We received no comments on this 

paragraph and, other than renumbering 

§ 1107.40 as § 1107.30, we have 

finalized it without change. 

5. Use of Other Labels 

Proposed § 1107.40(d) would allow a 

manufacturer or private labeler to use 

another label on the consumer product, 

as long as such label does not alter or 

mislead consumers as to the meaning of 

the label described in proposed 

§ 1107.40(b). A manufacturer or private 

labeler would not be allowed to imply 

that the CPSC has tested, approved, or 

endorsed the product. 

In reviewing the comments submitted 

regarding labels and proposed subpart 

D, we noticed that proposed 

§ 1107.40(d) (renumbered as 

§ 1107.30(d) in the final rule) could be 

misunderstood to imply that an 

alternative label may be used in place of 

the label specified in § 1107.40(b). 

Therefore, on our own initiative, we 

have revised § 1107.30(d) to state that 

other labels, in addition to the label 

specified in § 1107.30(b), may be placed 

on the product, as long as the additional 

labels do not change the meaning of the 

label specified in § 1107.30(b). 

F. Other Comments Received 

Several commenters raised questions 

on whether the final rule should contain 

‘‘safe harbors’’ (where certain actions 

are considered to be complying with a 

particular requirement), and questioned 

the rule’s effective date. Other 

commenters raised issues that were 

outside the scope of the rulemaking, 

such as whether a particular product 

was a ‘‘children’s product’’ or raised 

concerns on matters pertaining to the 

accreditation of third party conformity 

assessment bodies. 

(Comment 84)—Two commenters 

suggested that the rule clearly should 

allow for recognition of ‘‘safe harbors’’ 

based upon adherence to national 

standards for good manufacturing 

practices, international ISO standards 

governing GMP, and industry-based 

GMP category-specific guidelines that 

manufacturers may use as evidence of 

their good faith commitment to attaining 

a high degree of assurance that their 

products meet or exceed applicable 

federal safety standards. The 

commenters noted that we have 

recognized that such programs may be 

considered evidence of meeting the 

requirements under the proposed rule 

but noted as well that we have not yet 

recognized our authority to provide for 

such safe harbors, claiming the CPSIA 

did not make such specific provision 

(75 FR at 28339). According to the 

commenters, specific statutory authority 

is not a precondition to an agency acting 

under its rulemaking and enforcement 

authority to recognize such safe harbors. 

The commenters contended that we 

should provide such recognition. 

(Response 84)—As we noted 

previously in the preamble to the 

proposed rule (75 FR at 28339), section 

14 of the CPSA does not contain a safe 

harbor exception, nor does it establish 

any criteria by which the Commission 

could recognize testing programs for 

purposes of a safe harbor. 

The final rule does not contain a safe 

harbor provision based upon a 

manufacturer’s participation in a 

voluntary or industry-sponsored 

program; nor have we recognized any 

such program to indicate compliance 

with the final rule. We note that ISO 

standards for good manufacturing 

practices are generally industry-specific 

in areas such as cosmetics, 

pharmaceutical operations, food 

handling, and medical devices, products 

largely beyond the CPSC’s jurisdiction. 

It is unlikely that any one GMP standard 

would be deemed workable or 

acceptable for all manufacturing 

methods for children’s products. 

(Comment 85)—One commenter 

noted that the preamble to the proposed 

rule refers to a 95 percent statistical 

significance level as constituting a ‘‘high 

degree’’ of assurance. The commenter 

asked whether the CPSC would consider 

95 percent probability or confidence 

level to be a safe harbor level. 

(Response 85)—In the preamble to the 

proposed rule, the 95 percent 

probability level was discussed as an 

alternative definition of a ‘‘high degree 

of assurance’’ that we considered and 

subsequently rejected. We ‘‘decided 

against defining ‘high degree of 

assurance’ with respect to a 95 percent 

probability or confidence level (or any 

other level of statistical confidence) 

because there may be difficulty in 

applying the statistical methods to all 

manufacturing processes’’ (75 FR at 

28344). Therefore, we do not consider a 

95 percent confidence level to constitute 

automatically a ‘‘high degree of 

assurance’’; nor do we consider it to 

constitute a safe harbor level for 

purposes of compliance with the final 

rule. Determining what constitutes a 

‘‘high degree of assurance’’ varies, 

depending upon the product 

manufactured and the manufacturing 

processes used. The determination must 

be made by individual manufacturers, 

based upon their knowledge of their 

products and manufacturing processes. 


emcdonald on DSK5VPTVN1PROD with RULES3
69518 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

(Comment 86)—One commenter 

noted that, for most major retailers, the 

creation of a product begins with a 

design specification that originates 12 

months or more prior to manufacture or 

import into the United States. The 

commenter said that retroactively 

applying all the requirements of the 

final rule would be unduly burdensome. 

The commenter added that 

manufacturers of compliant products 

that are currently on retailers’ shelves 

may not have any or all of the 

components of a reasonable testing 

program. Generating this documentation 

‘‘after the fact’’ is simply not possible. 

The commenter asked that the rule 

apply only to products whose 

development begins 180 days on or after 

adoption. Accordingly, products would 

begin to be certified based upon a 

reasonable testing program with all 

accompanying documentation 

approximately 18 months after adoption 

of the final rule. 

One commenter suggested that we set 

the effective date at one year from the 

publication of the final rule because that 

is how long it would take their industry 

to change its manufacturing processes to 

be able to comply with the requirements 

of a reasonable testing program. 

Another commenter said that they 

simply do not have the staff or the 

resources to get the third party testing 

done on all of the products that could 

fall within the definition of ‘‘children’s 

product’’ and record it in a data 

collection and storage system (yet to be 

designed and implemented) within the 

180-day timeframe mentioned in the 

preamble to the proposed rule. That 

commenter suggested that they needed 

at least 365 days, and therefore, they 

requested that we extend the stay of 

enforcement until February 2012. 

(Response 86)—The preamble to the 

proposed rule indicated that a final rule 

would become effective 180 days after 

its date of publication in the Federal 

Register (75 FR at 28361). However, on 

August 12, 2011, the President signed 

H.R. 2715 into law. H.R. 2715 revised 

the CPSIA in several different ways, and 

it also affected section 14(i)(2)(B)(ii) of 

the CPSA. H.R. 2715 also created a new 

section 14(i)(3)(B) of the CPSA, which 

requires us, no later than one year after 

H.R. 2715’s date of enactment, to review 

the public comments (on opportunities 

to reduce the costs of third party testing 

requirements), and it permits us to 

‘‘prescribe new or revised third party 

testing regulations,’’ if we determine 

that ‘‘such regulations will reduce third 

party testing costs consistent with 

assuring compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations.’’ 

Consequently, we have finalized those 

provisions that H.R. 2715 did not affect 

directly. We also have decided to make 

the final rule effective 15 months after 

date of publication in the Federal 

Register so that parties can begin taking 

steps to develop internal processes, 

such as recordkeeping, and so that we, 

and interested parties, can consider how 

H.R. 2715 interacts with the final rule. 

We note that the effective date for the 

final rule is not calculated based on 

when development of a product begins, 

but rather, is calculated based on the 

date the product is manufactured. The 

requirements of the final rule apply only 

to products manufactured on or after the 

effective date of the final rule, and they 

do not apply retroactively to products 

already manufactured and certified. 

(Comment 87)—One commenter 

expressed concern that the rule has the 

potential to multiply the current volume 

of product testing by several fold and 

that third party conformity assessment 

bodies will be unable to provide 

accurately and efficiently the increased 

testing capacity needed by retailers/ 

importers to comply with this rule. The 

commenter asserted that currently, 

without the rule being in effect, retailers 

already are experiencing delayed 

turnarounds in product testing, and it is 

not uncommon to have special requests 

denied due to the current backlog in 

testing. 

The commenter also expressed 

concern that the increased testing 

demand may affect laboratory 

execution, potentially resulting in 

incorrect laboratory results, which may 

cause compliant product to be lost, or 

may allow noncompliant product to 

enter commerce. The commenter said 

that if the capacity of the third party test 

conformity assessment bodies is 

exceeded, retailers’ and manufacturers’ 

ability to meet the rule’s effective date 

could be jeopardized. The commenter 

asked that the third party conformity 

assessment body capacity issue be taken 

into consideration when establishing 

the effective date of the final rule. 

(Response 87)—We are aware that 

implementation of section 14(a)(2) of 

the CPSA potentially could result in 

insufficient testing capacity at CPSCaccepted third party conformity 

assessment bodies. We note that in the 

majority of the notices of requirements 

that have issued since 2008, there have 

been very few claims of insufficient 

capacity, and when such issues have 

arisen, we have taken steps to address 

the matter (see 75 FR 34360, June 17, 

2010). We intend to monitor and 

address, if possible, any capacity issues 

that arise after the final rule becomes 

effective. 

(Comment 88)—One commenter 

objected to the application of the 

regulation to some juvenile furniture. 

The commenter stated that it is difficult 

to estimate the cost of testing for 

children’s products when we have not 

yet decided on the definition of a 

children’s product. Another commenter 

generally supported the idea of third 

party testing of children’s products but 

was unclear about what products are 

included in the category of children’s 

products. 

(Response 88)—The final rule does 

not address what products fall within 

the definition of ‘‘children’s products’’; 

and therefore, the comment is outside 

the scope of the rule. However, after the 

comment was submitted, we issued an 

interpretative rule (now codified at 16 

CFR part 1200) regarding the definition 

of children’s product, providing the 

guidance the commenter is seeking. 

(Comment 89)—One commenter 

wondered whether a manufacturer or 

importer of a children’s product subject 

to a children’s product safety rule for 

which no third party testing conformity 

assessment bodies have been accredited 

by CPSC, is required to certify the 

product based on such testing. The 

commenter also wondered whether an 

importer is prohibited from importing 

the children’s product until we accredit 

third party testing conformity 

assessment bodies for the children’s 

product safety rule. 

(Response 89)—The final rule does 

not address the issuance of notices of 

requirements for accreditation of third 

party conformity assessment bodies; and 

therefore, the comment is outside the 

scope of the rule. However, if there are 

no CPSC-accepted third party 

conformity assessment bodies whose 

scope includes a rule applicable to a 

children’s product, those products are 

not prohibited from being imported. The 

children’s products must still comply 

with the requirements of the applicable 

children’s product safety rules. For 

example, if a rule established a limit of 

X for a particular chemical in children’s 

products, but there were no CPSCaccepted third party conformity 

assessment bodies to test for X, the 

children’s product would still be subject 

to the limit of X for that particular 

chemical; the absence of a CPSCaccepted third party conformity 

assessment body would not mean that 

the limit no longer applies. 

(Comment 90)—One commenter 

recommended that conformity 

assessment bodies should: (a) Comply 

with the standards in ISO/IEC Guide 65, 

or (b) in fulfillment of the requirements 

in ISO/IEC 17025:2005, during each 

audit review and resubmission of CPSC 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69519 

Form 223, demonstrate independence 

from ‘‘* * * financial and other 

pressures and influences that may 

adversely affect the quality of their work 

* * *’’; the commenter also suggested 

requirements for audits of conformity 

assessment bodies. 

Another commenter expressed 

ongoing concern over the distinct 

possibility that accredited testing 

organizations, especially ‘‘firewalled’’ 

and ‘‘government laboratories,’’ could 

be subject to influence and threats to 

impartiality by outside or related 

interests. The commenter expressed 

concern that the new audit procedures 

stated that all types of third party 

conformity assessment bodies: 

Independent, firewalled suppliers, and 

government-owned or -controlled would 

be treated the same and were all called 

third party conformity assessment 

bodies. The commenter stated that these 

different types of conformity assessment 

bodies have different modes of 

operation, and they need to be treated 

differently by us in both the auditing 

and accreditation requirements. The 

commenter suggested that we require 

applicants to submit the evidence used 

to validate the fulfillment of ISO/IEC 

17025:2005 requirements for the 

laboratory to ‘‘have arrangements to 

ensure that its management and 

personnel are free from any undue 

internal and external commercial, 

financial and other pressures and 

influences that may adversely affect the 

quality of their work,’’ not only as part 

of their application to the CPSC, but 

also on an ongoing basis, as part of each 

audit review and resubmission of CPSC 

Form 223. 

Two commenters stated that the 

proposed rule fails to differentiate 

between firewalled and independent 

conformity assessment bodies. 

According to one commenter, a 

manufacturer can submit samples to its 

firewalled conformity assessment body 

even if its reasonable testing program 

fails to provide a high degree of 

assurance of compliance with the 

applicable children’s product safety 

rules. The commenter sought 

clarification of the provision that a 

manufacturer of children’s products 

with a reasonable testing program may 

submit samples to its firewalled 

conformity assessment body every two 

years. 

(Response 90)—The final rule does 

not address the requirements for 

conformity assessment bodies; and 

therefore, the comments are outside the 

scope of the rule. Conformity 

assessment body requirements will be 

addressed in a separate rulemaking. 

Further, section 14(f) of the CPSA 

defines third party, firewalled, and 

governmental conformity assessment 

bodies. 

(Comment 91)—Two commenters 

recommended that we consider a 

number of steps to ensure that third 

party conformity assessment bodies are 

protected against undue influence. 

These included the following: (1) 

Adopting the requirements in Clause 4.2 

of the ISO/IEC Guide 65; (2) using the 

OSHA NRTL program as a model for 

laboratory accreditation; and (3) 

requiring all laboratories applying to the 

Commission to submit evidence that 

they fulfilled ISO/IEC 17025:2005 

section 4.1.5 b. One commenter made 

the recommendation for ‘‘firewalled’’ 

conformity assessment bodies. Another 

commenter would require annual 

reassessments of third party conformity 

assessment bodies. 

(Response 91)—The final rule does 

not address undue influence 

requirements for third party conformity 

assessment bodies; and therefore, the 

comments are outside the scope of this 

rule. This rule establishes the 

requirements for manufacturers to 

safeguard against the exercise of undue 

influence on third party conformity 

assessment bodies. 

(Comment 92)—Several commenters 

submitted comments on the concurrent 

rulemaking for component part testing 

in proposed 16 CFR part 1109. 

(Response 92)—The final rule does 

not establish the requirements for 

component part testing; and therefore, 

these comments are outside the scope of 

this rule. We have, instead, considered 

those comments in that rulemaking. 

(See Conditions and Requirements for 

Relying on Component Part Testing or 

Certification, or Another Party’s 

Finished Product Testing or 

Certification, to Meet Testing and 

Certification Requirements (16 CFR part 

1109)). 

(Comment 93)—One commenter 

opined that an existing third party 

certification system under the OSHA 

NRTL program, in conjunction with 

testing being carried out in testing 

facilities accredited to ISO/IEC 17025, is 

the preferred method for product 

certification for the CPSC. The 

commenter recommended that we 

consider a similar program or an 

accredited certification program that 

meets the requirements of ISO/IEC 

Guide 65 and ISO/IEC Guide 67. 

(Response 93)—The final rule does 

not address certification systems or 

accreditation, such as ISO/IEC Guides 

65 and 67; and therefore, the comment 

is outside the scope of this rule. 

(Comment 94)—Several commenters 

asked us to exempt silk from 16 CFR 

part 1610. They argued that the 

regulation exempts plain surface fabrics 

weighing at least 2.6 ounces per square 

yard and fabrics made from acrylic, 

modacrylic, nylon, olefin, polyester, and 

wool, but not silk. The commenters 

stated that silk’s reaction to fire is 

comparable to wool and better than the 

synthetics that are exempted. 

(Response 94)—The final rule does 

not address 16 CFR part 1610; and 

therefore, the comments are outside the 

scope of this rule. 

(Comment 95)—One commenter 

noted that heavy element and phthalates 

testing use some chemicals. The 

commenter stated that, with increased 

testing, there will be more chemical 

waste, which may not be desirable. 

(Response 95)—The final rule does 

not address testing methods for specific 

substances; and therefore, the comment 

is outside the scope of the rule. 

(Comment 96)—One commenter 

suggested developing an exemption list 

for vinyl fabrics produced in accordance 

with 16 CFR part 1611, Standard for the 

Flammability of Vinyl Plastic Film, 

using a process similar to that used to 

develop the exemption list in 16 CFR 

part 1610, Standard for the 

Flammability of Clothing Textiles. In the 

latter case, testing over a number of 

years showed that certain types of 

fabrics always produce passing results 

when tested according to 16 CFR part 

1610, and those types of fabrics 

eventually were exempted from the 

standard. 

(Response 96)—The final rule does 

not address 16 CFR part 1611; and 

therefore, the comment is outside the 

scope of the rule. 

(Comment 97)—One commenter 

disagreed that a standard of general 

application to all consumer products in 

a category should be considered a 

‘‘children’s product safety rule’’ for 

purposes of the CPSIA. 

(Response 97)—The final rule 

establishes the requirements for the 

testing and certification of children’s 

products and for the labeling of 

compliant consumer products. 

Determinations of whether a particular 

safety standard is a children’s product 

safety rule are outside the scope of this 

rule. 

(Comment 98)—One commenter 

suggested that we consider developing 

training guidelines for the regulated 

community and testing laboratories that 

explain key elements of a reasonable 

testing program for non-children’s and 

children’s products. The guidelines 

could include helpful training aids and 

presentations to increase knowledge and 

understanding. The guidelines could 

include helpful examples and scenarios 


emcdonald on DSK5VPTVN1PROD with RULES3
69520 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

for most common issues (e.g., 

developing a random sampling program) 

and even infrequent but complex issues 

(e.g., traceability for raw materials and 

product components). 

(Response 98)—The final rule is 

limited to establishing the requirements 

for testing and certification for 

children’s products and for labeling of 

consumer products as compliant; 

therefore, the comment is outside the 

scope of the rule. Further, we have 

reserved proposed subpart B (the 

reasonable testing program for nonchildren’s products) for future 

consideration. We may consider 

establishing training programs in the 

implementation of the final rule. 

(Comment 99)—One commenter 

noted that the proposed rule had to be 

worded very generally to be applicable 

to a wide range of products. This has 

had the effect of making it more difficult 

to understand how the rules will be 

applied in any specific industry. The 

commenter suggested that we conduct 

regional, industry-specific workshops to 

explain to the regulated manufacturers 

how these general rules will apply to 

their existing procedures and where 

new regulatory obligations exist. 

(Response 99)—The final rule is 

limited to establishing the requirements 

for testing and certification for 

children’s products and for labeling of 

consumer products as compliant; 

therefore, the comment is outside the 

scope of the rule. We may consider 

establishing regional industry-specific 

workshops in the implementation of the 

final rule. 

(Comment 100)—One commenter 

recommended that the labels for toys be 

used to communicate not only 

compliance with the standards, but also 

the appropriate age range for the toy. 

The commenter said that the European 

Union uses a universal mark that 

indicates the inappropriate age ranges of 

a toy if it presents a choking hazard. The 

commenter said that the CPSC’s 

program could expand on that concept, 

by recommending labeling that 

caregivers can use to separate toys 

intended for siblings of differing ages, 

while also preventing parents and other 

caregivers from buying toys that may be 

inappropriate for the age of the child. 

The commenter believes that this could 

help enhance toy safety by reducing 

children’s exposure to inappropriate 

toys. 

(Response 100)—The final rule does 

not address labeling for the appropriate 

ages ranges for a toy; therefore, the 

comment is outside the scope of the 

rulemaking. Section 14(i)(2)(A) of the 

CPSA requires us to implement a 

program by which a manufacturer may 

label a product to comply with the 

certification requirements of section 

14(a) of the CPSA. However, the CPSC 

staff has issued Age Determination 

Guidelines: Relating Children’s Ages to 

Toy Characteristics and Play Behavior, 

T. P. Smith (Ed.) (2002) (which can be 

found on the CPSC Web site at http:// 

www.cpsc.gov/BUSINFO/adg.pdf) 

which addresses the issue raised by the 

commenter. 

(Comment 101)—One commenter 

asserted that the best approach would 

be to allow businesses to manage their 

compliance risks as best they can 

because ‘‘* * * the prophylactic 

approach to testing adopted by the 

CPSC will inevitably put many small or 

micro businesses into bankruptcy 

* * *. If the law does not permit the 

agency to adopt sensible rules that allow 

businesses to manage their compliance 

risk as best they can (where the 

standards remain in place, but the 

government stops trying to tell 

businesses HOW to comply), then the 

Commission must finally tell Mr. 

Waxman what he doesn’t want to hear— 

that his law is broken and can’t be fixed 

* * *.’’ The commenter then wrote: 

‘‘* * * I don’t believe the agency can 

devise sensible regulations to fix this 

problem short of a legislative change.’’ 

(Response 101)—Comments about the 

merits of section 14 of the CPSA or the 

CPSIA are beyond the scope of this 

rulemaking. However, on August 12, 

2011, the President signed into law H.R. 

2715, which amended the CPSIA in 

several respects. One provision provides 

relief for small batch manufacturers. 

Another provision in H.R. 2715 requires 

the CPSC to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. H.R. 

2715 directs the CPSC to seek public 

comment on seven specific issues, 

including other techniques for lowering 

the cost of third party testing consistent 

with assuring compliance with the 

applicable consumer product safety 

rules, bans, standards, and regulations. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires 

the CPSC to review the public 

comments and states that the CPSC may 

prescribe new or revised third party 

testing regulations if we determine that 

such regulations will reduce third party 

testing costs consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 

(Comment 102)—One commenter, 

who manufactures die-cast metal toys, 

commented that the 90 ppm lead 

content limit is too low to allow use of 

the usual aluminum for casting their 

products, even though the same metal is 

used to make cooking utensils. 

Furthermore, the commenter stated 

that it costs $3,700 to test one unit and 

that the market will not absorb the costs 

of testing multiple units per batch. The 

commenter implied that these costs 

would cause it to go out of business or 

make its products in China. The 

commenter expressed the belief that it 

should not have to test using third party 

conformity assessment bodies because: 

1. They are ISO 9001:2008 compliant. 

2. They document all of their supplier 

receipts of metal, plastic, and powder 

paint materials. 

3. They conduct a metal analysis for 

each production run with their 

spectrometer. 

(Response 102)—The final rule does 

not address lead content and surface 

coating limits and; therefore, comments 

on the allowable concentration levels 

are outside the scope of this rule. 

However, H.R. 2715 directs the CPSC 

to seek public comment on seven 

specific issues, including the extent to 

which evidence of conformity with 

other national or international 

governmental standards may provide 

assurance of conformity to consumer 

product safety rules, bans, standards, or 

regulations, and the extent to which 

technology, other than the technology 

already approved by the Commission, 

exists for third party conformity 

assessment bodies to test or to screen for 

testing consumer products subject to a 

third party testing requirement. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. 

IV. Regulatory Flexibility Act 

A. Introduction 

We have examined the impacts of the 

final rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). The 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would reduce any significant 

impact of a rule on small entities. 

Several sections that were included in 

the proposed rule are not included in 

the final rule, but they are being 

reserved for future rulemaking. 

Proposed subpart B, pertaining to a 

reasonable testing program for nonchildren’s products, is not included in 

the final rule, but we may address the 

issue in a future rulemaking. The 

proposed section pertaining to the 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69521 

selection of random samples for 

children’s products (§ 1107.22) is not 

included in the final rule, and it is 

addressed in a separate rulemaking 

published elsewhere in this issue of the 

Federal Register. Proposed § 1107.21(d), 

which would provide a partial 

exemption from periodic testing for lowvolume products is not included in the 

final rule. The reason for omitting 

proposed § 1107.21(d) from the final 

rule is that H.R. 2715 asked us to 

examine means to reduce the cost of 

third party testing requirements 

consistent with assuring compliance 

with any applicable consumer product 

safety rule, ban, standard, or regulation. 

It also contained special rules for small 

batch manufacturers and directed us to 

consider alternative testing 

requirements or to exempt small batch 

manufacturers from certain third party 

testing requirements. Given these new 

statutory obligations resulting from H.R. 

2715, we are reserving § 1107.21(e) 

(formerly proposed § 1107.21(d)) so that 

we may consider issues related to cost, 

low-volume products, and small batch 

manufacturers more fully. Finally, 

proposed § 1107.25, which would 

establish requirements for remedial 

action for children’s products, has not 

been included in the final rule. 

Before promulgating a final rule, the 

Regulatory Flexibility Act requires 

agencies to prepare a final regulatory 

flexibility analysis of the rule that 

analyzes the impact that the rule will 

have on small entities. The final 

regulatory flexibility analysis must 

contain: 

(1) A succinct statement of the need 

for, and objectives of, the rule; 

(2) a summary of the significant issues 

raised by the public comments in 

response to the initial regulatory 

flexibility analysis, a summary of the 

assessment of the agency of such issues, 

and a statement of any changes made in 

the proposed rule as a result of such 

comments; 

(3) a description of and an estimate of 

the number of small entities to which 

the rule will apply, or an explanation of 

why no such estimate is available; 

(4) a description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the rule, 

including an estimate of the classes of 

small entities which will be subject to 

the requirement and the type of 

professional skills necessary for 

preparation of the report or record; and 

(5) a description of the steps the 

agency has taken to minimize the 

significant economic impact on small 

entities consistent with the stated 

objectives of applicable statutes, 

including a statement of the factual, 

policy, and legal reasons for selecting 

the alternative adopted in the final rule 

and why each one of the other 

significant alternatives to the rule 

considered by the agency which affect 

the impact on small entities was 

rejected. 

B. Need for, and Objectives of, the Rule 

Section 14(a)(2) of the CPSA requires 

that every manufacturer of a children’s 

product that is subject to a children’s 

product safety rule certify that the 

product complies with the applicable 

children’s product safety rule based on 

testing conducted by a third party 

conformity assessment body accredited 

to conduct such tests. The final rule 

establishes requirements and 

procedures for manufacturers to certify 

children’s products under this section of 

the CPSA. 

Section 14(i)(2)(A) of the CPSA 

requires that we initiate a program by 

which a manufacturer or private labeler 

may label a product as complying with 

the applicable safety rules. The statute 

also requires us to establish protocols 

and standards: (i) For ensuring that a 

children’s product is tested periodically 

and when there has been a material 

change in the product, (ii) for the testing 

of representative samples to ensure 

continued compliance, (iii) for verifying 

that a product tested by a conformity 

assessment body complies with 

applicable safety rules, and (iv) for 

safeguarding against the exercise of 

undue influence on a conformity 

assessment body by a manufacturer or 

private labeler. With the exception of 

items (ii) (standards and protocols for 

the testing representative samples), and 

(iii) (establish protocols and standards 

for verifying that a product tested by a 

conformity assessment body complies 

with applicable safety rules), the final 

rule implements these requirements. 

The objective of the final rule is to 

reduce the number of children’s 

products that are distributed each year 

that fail to comply with one or more 

children’s product safety rules. The 

applicable children’s product safety 

rules were established to reduce the 

unreasonable risk of injury or death due 

to foreseeable hazards associated with 

particular children’s products. 

C. Comments on the Initial Regulatory 

Flexibility Analysis, and Our Responses 

The preamble to the proposed rule 

contained our initial regulatory 

flexibility analysis (76 FR at 28352 

through 28360). Several commenters 

addressed issues pertaining to that 

analysis. 

(Comment 103)—One commenter 

noted that in estimating the number of 

firms that could be impacted by the 

proposed rule, the book publishing 

industry (NAICS code 511130) and 

printing industry (NAICS code 323117) 

were not included. The commenter 

recommended their inclusion for the 

final regulatory flexibility analysis. 

(Response 103)—We acknowledge 

that the initial regulatory flexibility 

analysis inadvertently omitted these 

industries. However, the recently 

enacted H.R. 2715 exempts ordinary 

books and ordinary paper-based printed 

materials from the third party testing 

requirements, so the commenter’s 

concern no longer applies. 

(Comment 104)—One commenter 

indicated that the cost of complying 

with the reasonable testing program 

requirements for furniture will vary 

according to: (1) Whether the furniture 

is children’s or non-children’s furniture; 

(2) whether the furniture is produced 

domestically or imported; and (3) 

whether the manufacturer produces a 

high or low-volume of products. Highvolume producers can rely on a 

component part certificate from their 

paint suppliers, and the cost of testing 

would be relatively low. Higher quality, 

lower volume producers would have 

greater difficulty because these items 

often are ‘‘made to order’’ and ‘‘as 

needed.’’ These producers will use 

small batches of finishes issued in a 

number of different finishing materials, 

each of which would need to be tested. 

(Response 104)—We agree that the 

costs of complying with the 

requirements will vary among products 

and manufacturers. Generally, the costs 

will be more significant for 

manufacturers of lower volume 

products. It should also be noted that 

proposed subpart B, which would 

contain the requirements applicable to 

non-children’s products, is not being 

finalized at this time. Therefore, the 

final rule does not impose any 

requirements on non-children’s 

furniture. 

(Comment 105)—Two commenters 

expressed concern about costs. One 

commenter noted that reliance on third 

party conformity assessment body 

testing raises costs and imposes 

production delays. Another commenter, 

a charitable organization that makes 

wooden toys for donation to needy 

children, commented that it lacks the 

resources to pay for certification testing 

and would need to discontinue 

activities unless granted an exemption 

or some other type of relief. 

(Response 105)—Section 14(a)(2) of 

the CPSA requires third party 

conformity assessment bodies to test 

children’s products for compliance with 

applicable children’s product safety 


emcdonald on DSK5VPTVN1PROD with RULES3
69522 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

rules. We recognize that testing costs 

may be substantial and may have a 

significant adverse affect on some 

manufacturers, especially small 

businesses that may have limited 

financial resources. We also recognize 

that the testing will take time and could 

result in some delays in the production 

process. 

Recently enacted H.R. 2715 requires 

us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. H.R. 

2715 directs us to seek public comment 

on seven specific issues, including 

techniques for lowering the cost of third 

party testing consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. Elsewhere in 

this issue of the Federal Register, we 

have published a notice seeking public 

comment on the issues in H.R. 2715. 

H.R. 2715 further requires us to review 

the public comments and states that we 

may prescribe new or revised third 

party testing regulations if we determine 

that such regulations will reduce third 

party testing costs consistent with 

assuring compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 

H.R. 2715 also requires us to consider 

alternative requirements for the covered 

products of small batch manufacturers 

and, if no alternative requirements are 

available or economically practical, 

exempts small batch manufacturers 

from the third party testing 

requirements, with some exceptions. 

Covered products are those for which 

fewer than 7,500 units were produced in 

the previous year, and a small batch 

manufacturer is one whose gross sales 

revenue from all consumer products in 

the previous calendar year was less than 

$1 million. In the case of toys, however, 

no alternative requirements or 

exemptions would be permitted for 

third party testing for the lead content 

of paint, small parts, and pacifiers. 

Where possible, we tried to reduce 

testing costs by allowing the use of 

component part testing. 

(Comment 106)—One commenter 

noted that the initial regulatory 

flexibility analysis acknowledged that 

the examples used only considered the 

out-of-pocket testing costs. Costs not 

considered in the examples include: 

Samples destroyed or damaged in 

testing; transportation of the samples; 

administrative costs for managing 

testing; administrative costs for 

managing the testing data and 

recordkeeping; an allocation of general 

management time; legal expenses, 

among other costs. The commenter 

estimated that, depending on the scale 

of the business, these costs will add 15 

to 50 percent to the out-of-pocket testing 

costs. 

The commenter also noted that the 

initial regulatory flexibility analysis 

considered the probability that some 

manufacturers or private labelers will 

have to test multiple samples to obtain 

the high degree of assurance required by 

the proposed rule. The commenter 

asserted that over the last 20 years of 

product testing at his company, 

multiple safety tests of the same product 

have not revealed anything useful. The 

commenter asserted that the testing rule 

is complex; that many small businesses 

will not have the skills necessary to 

understand what is expected of them in 

terms of compliance; and that many 

small businesses will exit the market for 

children’s products. 

(Response 106)—The initial 

regulatory flexibility analysis focused 

on the cost of third party testing because 

it will likely be the most significant cost 

for small manufacturers of children’s 

products. Considering only the third 

party testing costs, the initial regulatory 

flexibility analysis found that the rule 

could have a significant impact on a 

substantial number of small entities. 

The initial regulatory flexibility analysis 

explicitly stated that the only costs 

considered in the analysis were the 

costs that the laboratories would charge 

to conduct the testing. The commenter 

is correct that the rule would impose 

other costs, including the cost of the 

samples destroyed in testing and freight, 

as well as the costs involved in 

administering and managing the testing 

and paperwork. The commenter’s 

estimate that these costs would add 15 

to 50 percent to the out-of-pocket testing 

costs, depending upon factors such as 

the product involved and the scale of 

the business, seems reasonable. 

The commenter also is correct that the 

initial regulatory flexibility analysis 

considered the impact on firms that had 

to test more than one sample of a 

product in order for the manufacturer to 

obtain a high degree of assurance that 

the product complies with the 

applicable product safety rules. 

However, the final rule does not specify 

the number of samples that must be 

tested. It is possible that if the 

commenter, as asserted, has never found 

multiple tests on its products to reveal 

anything useful, then the products 

manufactured could be of such uniform 

composition and quality that the 

number of samples that the commenter 

will be required to submit for testing 

will be small. However, because the rule 

requires that every children’s product 

subject to a children’s product safety 

rule be tested periodically by a third 

party conformity assessment body, the 

commenter might need to conduct more 

testing than the commenter believes is 

necessary. 

We acknowledge that the rule is 

complex, and some small businesses 

might have to hire outside consultants, 

such as lawyers, statisticians, or quality 

control experts to help them comply 

with the regulations. As a result, some 

small firms may exit the market for 

children’s products. 

(Comment 107)—One commenter 

stated that the testing rule would 

accelerate the decline of domestic 

manufacturing firms, as more 

manufacturers go offshore to minimize 

the cost of testing. The commenter 

asserted that the furniture industry will 

have no choice but to close down more 

and more factories in the United States 

and take those jobs off shore to benefit 

from the lower testing costs. The 

commenter stated that some small 

manufacturers have abandoned plans to 

offer products intended for the youth 

market. 

(Response 107)—The initial 

regulatory flexibility analysis noted that 

the costs of some third party tests are 

less expensive abroad than they are in 

the United States. For example, while 

typical prices for lead content tests 

range from $50 to more than $100 in the 

United States, the same lead content 

test, in some cases, can be obtained for 

as little as $20 in China (75 FR at 

28355). Higher third party testing costs 

in the United States would be an 

incentive for manufacturers to produce 

children’s products abroad, to take 

advantage of the lower testing costs. 

Given all of the factors that go into a 

decision by a manufacturer to produce 

consumer products abroad rather than 

in the United States, the impact of third 

party testing costs on such a decision 

might be small. It seems unlikely that 

the independent effect of higher third 

party testing costs, by itself, would 

result in a large number of factories in 

the United States closing down. With 

regard to small domestic manufacturers, 

it is possible that the third party testing 

costs associated with the children’s 

furniture could lead some to 

manufacturers to reduce their children’s 

furniture product lines or even cease 

their production of children’s furniture. 

Any small manufacturer of children’s 

furniture who qualifies as a small batch 

manufacturer might be offered relief by 

the alternative requirements or 

exemptions that are provided by H.R. 

2715; however, matters regarding the 

small batch manufacturer’s exception in 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69523 

H.R. 2715 are outside the scope of this 

rulemaking. Elsewhere in this issue of 

the Federal Register, we have published 

a notice seeking public comment on the 

issues in H.R. 2715, including other 

techniques for lowering the cost of third 

party testing consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations, pursuant to 

H.R. 2715. 

(Comment 108)—One commenter 

stated that the cost to test a finish used 

in the furniture industry is about $50 

(which is consistent with the discussion 

of testing costs in the initial regulatory 

flexibility analysis). A youth bed, which 

is also subject to the lead content 

requirements of section 101 of the 

CPSIA, might require 29 tests at a third 

party testing facility, which would bring 

the total cost of lead testing to $1,450. 

In addition, testing to the bunk bed 

standard would add $600 to $800 to the 

cost. A crib or toddler bed would cost 

an additional $750 to $765 ($450 to 

$520 in China) to test to the relevant 

children’s product safety rules. The cost 

of testing other items of youth furniture, 

such as desks, entertainment centers, 

and bookcases, averages approximately 

$235. These costs do not include the 

cost of the samples, freight, random 

sampling, or the cost for employees to 

track and administer the recordkeeping 

requirements. 

(Response 108)—As described in the 

initial regulatory flexibility analysis (75 

FR at 28352 through 28362), the testing 

of some children’s products by third 

party conformity assessment bodies can 

be costly. The testing costs described by 

the commenter do not appear to be 

unreasonable estimates, based on cost 

estimates we obtained. In cases where 

the same component is used in more 

than one product, manufacturers may be 

able to reduce their testing costs by 

using component part testing. However, 

component part testing will not offer 

any relief from the costs of tests that 

must be performed on the finished 

product, such as tests for conformity to 

the crib and bunk bed standards. 

(Comment 109)—One commenter 

stated that furniture manufacturers who 

deal in high-quality but lower volume 

furniture manufacturing may offer 

products with between 30 and more 

than 2,000 possible combinations of 

finishes. Many of these finishes are 

custom or made to order, so that a batch 

can range from a 5-gallon bucket to a 55- 

gallon drum. Each custom finish 

consists of at least 10 different 

materials. The manufacturer must create 

a panel for each possible combination of 

finishing materials and then have it 

analyzed by a third party testing facility. 

An x-ray fluorescence (XRF) gun is then 

used to verify that the finished piece, in 

fact, complies with the lead-in-paint 

standard. It is estimated that 6 to 10 

employees will be required to track the 

testing and compile the certificates of 

conformity. It is estimated that the cost 

to comply with the rule for nonchildren’s products could range from 

$200,000 to $410,000, annually. 

(Response 109)—We received many 

comments on proposed subpart B, 

which was concerned with reasonable 

testing programs for non-children’s 

products. The comments raised many 

practical issues, which illustrates the 

difficulty of drafting a regulation that 

can apply to many different types of 

products and manufacturing processes 

and still provide sufficient guidance to 

enable manufacturers to implement the 

requirements effectively. Consequently, 

we are deferring action with respect to 

finalizing subpart B. Instead, we will 

reserve subpart B in the final rule and 

continue evaluating the issues raised in 

the comments. 

It should be noted, however, that 

although we are not finalizing subpart B 

at this time, manufacturers of nonchildren’s products that are subject to a 

product safety rule, ban, standard, or 

regulation are still obligated by the 

CPSA, as amended by the CPSIA, to 

certify that their products comply with 

all applicable safety rule, based on a test 

of each product or a reasonable testing 

program. 

In the case of testing the lead content 

of paint, which the commenter 

mentioned, the use of component part 

or composite testing—as would be 

allowed by the final rule on component 

part testing—might allow some 

manufacturers to reduce their testing 

costs. For example, if the same 10 raw 

materials (and only those materials) are 

combined in different portions to 

produce 30 different finishes, a 

manufacturer could test the lead content 

of each of the materials, and if each of 

the materials met the lead content 

requirement, then the manufacturer 

would not need to test each of the 30 

finishes separately. 

(Comment 110)—One commenter 

stated that because the cost of testing 

and recordkeeping will be passed on to 

the consumer, this could create an 

‘‘upside down’’ market in furniture, in 

which youth furniture is more 

expensive than adult furniture. This 

could lead some consumers to purchase 

‘‘adult’’ furniture for children instead of 

purchasing youth furniture that has 

been third party tested. 

(Response 110)—Section 14(a)(2) of 

the CPSA requires third party testing of 

children’s products, including 

children’s and youth furniture. 

Depending upon the structure of the 

market and market conditions, some or 

all of the testing costs may be passed on 

to consumers. We cannot determine 

whether passing on these costs will 

make children’s furniture—in any 

absolute sense—to be more expensive to 

purchase than adult furniture; but 

passing on these costs to consumers is 

likely to increase the relative price of 

children’s furniture, and it could 

provide a price incentive for parents to 

substitute adult furniture for children’s 

furniture. 

(Comment 111)—One commenter 

stated that the proposed rule will 

impose significant new costs on the 

mattress industry because mattresses are 

already subject to an expensive 

mandatory testing program pursuant to 

16 CFR part 1633. The commenter 

asserted that because most 

manufacturers of mattresses are small 

businesses, the proposed rule would 

have a substantially greater impact on 

the mattress industry, given the nature 

of the products, the types of standards 

that the products must meet, the 

destructive nature of the testing 

involved, and the cost of the samples 

tested. 

The commenter also noted that 

mattress testing entails other costs, such 

as: the cost of the samples tested, the 

laboratory test fees, freight costs to ship 

samples to the laboratory, and the 

manufacturers’ staff sent to witness the 

test. The total cost of conducting a full 

test for 16 CFR part 1633 can range from 

$850 to $1,650 per sample tested, plus 

added travel costs and salary expenses 

for company personnel to witness the 

test. The commenter urged us to take 

into account the significant new costs 

that the rules will impose on the 

mattress industry, which is comprised 

overwhelmingly of small businesses. 

(Response 111)—We acknowledge 

that the rule could impose additional 

costs on some firms. However, section 

14(a)(2) if the CPSA requires third party 

testing of children’s products that are 

subject to an applicable children’s 

product safety rule. 

Additionally, on August 12, 2011, the 

President signed into law H.R. 2715, 

which amended the CPSIA in several 

respects. One provision in H.R. 2715 

requires us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. H.R. 

2715 directs us to seek public comment 

on seven specific issues. These issues 

include: 


emcdonald on DSK5VPTVN1PROD with RULES3
69524 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

• The extent to which manufacturers 

with a substantial number of 

substantially similar products subject to 

third party testing may reasonably make 

use of sampling procedures that reduce 

the overall test burden without 

compromising the benefits of third party 

testing; and 

• Other techniques for lowering the 

cost of third party testing consistent 

with assuring compliance with the 

applicable consumer product safety 

rules, bans, standards, and regulations. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715. H.R. 2715 further requires us 

to review the public comments and 

states that we may prescribe new or 

revised third party testing regulations if 

we determine that such regulations will 

reduce third party testing costs 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

Another provision of H.R. 2715 

created a new section 14(i)(4) of the 

CPSA to provide for special rules for 

small batch manufacturers. The 

provision contemplates the possible 

development of alternative testing 

requirements for ‘‘covered products’’ 

made by ‘‘small batch manufacturers.’’ 

The provision also provides for possible 

exemptions of small batch 

manufacturers from the third party 

testing requirements and imposes 

certain limits on third party testing 

requirements. A covered product is a 

consumer product where no more than 

7,500 units of the same product were 

manufactured by a small batch 

manufacturer in the previous calendar 

year, and a small batch manufacturer is 

a manufacturer that had no more than 

$1 million in gross revenue from sales 

of all consumer products in the previous 

calendar year. Any small mattress 

manufacturer who meets the definition 

of a ‘‘small batch manufacturer’’ might 

benefit from this provision when it is 

implemented. 

(Comment 112)—One commenter 

stated that the discussion of sample size 

is unrealistic. An example was used in 

the initial regulatory flexibility analysis 

that provided the sample sizes that 

would be required to meet a specified 

statistical confidence level, assuming 

that both the historical variability 

(standard deviation) and the historical 

mean of the variable (lead content) are 

known. The commenter stated that 

continuously variable data on 

commonly available testing reports is 

generally not provided by the 

laboratories, and data for samples with 

a result below the method detection 

limit is generally provided in the form 

‘‘< X ppm,’’ where X is the method 

detection limit. The commenter noted 

that these data cannot be included for 

calculations of the mean or standard 

deviation. The commenter stated that 

the example used is invalid, unless the 

data can be captured and tracked in full 

resolution, which is not the current 

state. 

(Response 112)—To the extent that 

continuously variable data from testing 

results are unavailable, the discussion of 

sample size in the initial regulatory 

flexibility analysis may be unrealistic. 

Because the example is not widely 

applicable, and because we are not 

requiring that the periodic third party 

testing be used to provide a high degree 

of statistical assurance (e.g., 95 percent 

confidence) that no children’s products 

violate consumer product safety 

standards, we have omitted the example 

from the final regulatory flexibility 

analysis. 

D. Small Entities To Which the Rule 

Will Apply 

By regulation (16 CFR part 1110), the 

domestic manufacturer or importer is 

responsible for ensuring that a 

consumer product is tested properly, 

and, based on the testing results, must 

certify that the product conforms to all 

applicable consumer product safety 

rules. Manufacturers of children’s 

products that are subject to a children’s 

product safety rule must certify that the 

children’s products comply with all 

applicable children’s product safety 

rules, based on testing conducted by 

third party conformity assessment 

bodies that are accredited to conduct 

such tests. The definition of a 

‘‘children’s product’’ is broad, and it 

includes bicycles, books, furniture, 

apparel, jewelry, televisions, electronic 

games, toys, and so on, if designed or 

intended primarily for a child 12 years 

of age or younger. Virtually all 

children’s products are subject to one or 

more children’s product safety rules. 

For example, the lead content of paint 

and all non-excluded accessible 

component parts of children’s products 

are subject to limits. Therefore, virtually 

all manufacturers of children’s products 

will have to certify, based on tests by 

accredited third party conformity 

assessment bodies that their products 

comply with the lead content limits. We 

have excluded from the requirement to 

test for lead content a few materials that 

inherently do not contain lead. The 

excluded materials are limited to 

materials such as: most fabrics, precious 

metals, paper, gemstones, and a limited 

number of other items, and the list can 

be found at 16 CFR 1500.91. We also 

have issued a rule excluding from the 

lead content requirements (16 CFR 

1500.87) inaccessible component parts 

in children’s products. Section 1(b)(3) of 

H.R. 2715 excludes certain used 

children’s products from testing for lead 

content. All other materials used in 

products intended for children must be 

tested for lead content. 

In addition to the requirements to test 

for lead content, manufacturers must 

test for conformity with a wide variety 

of other children’s product safety rules. 

For example, there are product safety 

rules that establish standards for 

children’s products, such as toys, cribs, 

bicycles, bicycle helmets, youth allterrain vehicles, bunk beds, baby 

walkers, and flammable clothing 

textiles. The CPSIA also limits the 

amount of six phthalates that can be 

present in children’s toys and child care 

articles; thus, many plastic component 

parts will need to be tested for phthalate 

content. A full list of the children’s 

product safety rules for which third 

party testing and certification will be 

required is given in Table 1. 

TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS

16 CFR part # (or test method or standard) Description 

1420 .......................................................................................................... All-Terrain Vehicles. 

1203 .......................................................................................................... Bicycle Helmets. 

1512 .......................................................................................................... Bicycles. 

1513 .......................................................................................................... Bunk Beds. 

1500.86(a)(5) ............................................................................................ Clacker Balls. 

1500.86(a)(7) and (8) ............................................................................... Dive Sticks and Other Similar Articles. 

1505 .......................................................................................................... Electrically Operated Toys or Articles. 

1615 .......................................................................................................... Flammability of Children’s Sleepwear, Sizes 0 through 6X. 

1616 .......................................................................................................... Flammability of Children’s Sleepwear, Sizes 7 through 14. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69525 

TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS—Continued 

16 CFR part # (or test method or standard) Description 

1610 .......................................................................................................... Flammability of Clothing Textiles. 

1632 .......................................................................................................... Flammability of Mattresses and Mattress Pads. 

1633 .......................................................................................................... Flammability (Open Flame) of Mattress Sets. 

1611 .......................................................................................................... Flammability of Vinyl Plastic Film. 

1219 .......................................................................................................... Full-Size Cribs. 

1215 .......................................................................................................... Infant Bath Seats. 

1216 .......................................................................................................... Infant Walkers. 

Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08, CPSC–CH– 

E1001–08.1 or 2005 CPSC Laboratory SOP).

Lead Content in Children’s Metal Jewelry. 

Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08 or CPSC–CH– 

E1001–08.1).

Lead Content in Children’s Metal Products. 

Sec. 101 of CPSIA (Test Method CPSC–CH–E1002–08 and/or CPSC– 

CH–E1002–08.1).

Lead Content in Children’s Non-Metal Products. 

1303 .......................................................................................................... Lead Paint. 

1220 .......................................................................................................... Non-Full-Size Cribs. 

1511 .......................................................................................................... Pacifiers. 

Sec. 108 of CPSIA (Test Method CPSC–CH–C1001–09.3 ) .................. Phthalate Content of Children’s Toys and Child Care Articles. 

1510 .......................................................................................................... Rattles. 

1501 .......................................................................................................... Small Parts Rule.

1630 .......................................................................................................... Surface Flammability of Carpets and Rugs. 

1631 .......................................................................................................... Surface Flammability of Small Carpets and Rugs. 

1217 .......................................................................................................... Toddler Beds. 

(ASTM F963) ............................................................................................ Toys. 

E. Number of Small Firms Affected 

We estimated the number of firms that 

could be impacted, by reviewing every 

industry in the North American 

Industrial Classification System 

(NAICS), and selecting industries with 

firms that could manufacture or sell any 

children’s product potentially covered 

by a consumer product safety rule. 

Firms are classified in the NAICS 

category that describes their primary 

activity. Therefore, firms that might 

manufacture or import consumer 

products covered by a safety rule as a 

secondary or tertiary activity may not 

have been counted. There is no separate 

NAICS category for importers. Firms 

that import products might be classified 

as manufacturers, wholesalers, or 

retailers. 

1. Manufacturers 

According to the criteria established 

by the U.S. Small Business 

Administration (SBA), manufacturers 

are generally considered to be small 

entities if they have fewer than 500 

employees. Table 2 shows the number 

of manufacturing firms by the North 

American Industrial Classification 

System (NAICS) categories that cover 

most children’s products that are subject 

to a product safety rule. Although there 

are more than 26,000 manufacturers that 

would be considered small in these 

categories, not all of these firms are 

engaged in manufacturing children’s 

products that are subject to a product 

safety rule. It would be expected that 

most firms engaged listed in the 

category, Doll, Toy, and Game, produce 

some products that are intended for 

children age 12 and younger. On the 

other hand, the Surgical Appliance and 

Supplies Manufacturing category 

includes crash helmets, but most other 

products in this category are not under 

our jurisdiction. 

TABLE 2—MANUFACTURERS

NAICS Code Description Small 

firms 

Total 

firms 

31411 .................................................... Carpet and Rug Mills ........................................................................................... 244 262 

315 ........................................................ Apparel Manufacturing ......................................................................................... 7,126 7,195 

316211 .................................................. Rubber and Plastic Footwear Manufacturing ...................................................... 43 45 

316212 .................................................. House Slipper Manufacturing ............................................................................... 1 1 

316219 .................................................. Other Footwear Manufacturing ............................................................................ 53 54 

326299 .................................................. All Other Rubber Product Manufacturing ............................................................. 622 666 

336991 .................................................. Motorcycle, Bicycle, and Parts Manufacturing ..................................................... 447 452 

33712 .................................................... Household and Institutional Furniture Manufacturing .......................................... 6,058 6,154 

33791 .................................................... Mattress Manufacturing ........................................................................................ 427 441 

339113 .................................................. Surgical Appliance and Supplies Manufacturing ................................................. 1,817 1,916 

33991 .................................................... Jewelry and Silverware Manufacturing ................................................................ 2,470 2,484 

33992 .................................................... Sporting and Athletic Goods Manufacturing ........................................................ 1,707 1,748 

33993 .................................................... Doll, Toy and Game Manufacturing ..................................................................... 694 705 

339942 .................................................. Lead Pencil and Art Good Manufacturing ........................................................... 124 129 

339999 .................................................. All Other Miscellaneous Manufacturing ............................................................... 4,646 4,695 

Total Manufacturers ...................................................................................... 26,479 26,947 

Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, 

Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: http://www2.

census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. 


emcdonald on DSK5VPTVN1PROD with RULES3
69526 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

3U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

Table.’’ Available at: http://www.census.gov/econ/ 

nonemployer/Revised%202008%20Data

%20With%202009%20Methodology%20

Applied.xls (last accessed 16 August 2011). 

4U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

Table.’’ available at http://www.census.gov/econ/

nonemployer/Revised%202008%20Data%20With

%202009%20Methodology%20Applied.xls (last 

accessed 16 August 2011). 

In addition to the manufacturers in 

Table 3, there were 25,184 nonemployer 

businesses classified in NAICS 315 

(Apparel Manufacturing) and 61,180 

classified in NAICS 3399 (Other 

Miscellaneous Manufacturers) in 2008. 

Nonemployer businesses are generally 

very small businesses with no 

employees. They are typically sole 

proprietorships, and they may or may 

not be the owner’s principal source of 

income. The average receipts for the 

nonemployer businesses classified in 

Apparel Manufacturing was about 

$31,000, and the average receipts for the 

nonemployer businesses classified 

Other Miscellaneous Manufacturers was 

about $41,000.3

2. Wholesalers 

Wholesalers would be impacted by 

the rule if they import any children’s 

product that is subject to a product 

safety rule. Wholesalers who obtain 

their products strictly from domestic 

manufacturers, or from other 

wholesalers, would not be impacted by 

the rule because the manufacturer or 

importer would be responsible for 

certifying the products. Table 3 shows 

the number of wholesalers by NAICS 

code that would cover most children’s 

products that are subject to a product 

safety rule. According to SBA criteria, 

wholesalers are generally considered to 

be small entities if they have fewer than 

100 employees. Although there are more 

than 78,000 wholesalers that would be 

considered small in these categories, not 

all of these firms are engaged in 

importing children’s products that are 

subject to a consumer product safety 

rule. A significant proportion of the 

firms classified as Toy and Hobby 

Goods and Supplies Merchant 

Wholesalers probably import at least 

some children’s products. However, the 

only firms classified as Motor Vehicle 

and Motor Vehicle Parts and Suppliers 

that would be impacted by the final rule 

are those that import all-terrain vehicles 

intended for children 12 years old or 

younger. 

TABLE 3—WHOLESALERS

NAICS Code Description Small 

firms 

Total 

firms 

4231 ...................................................... Motor Vehicle and Motor Vehicle Parts and Suppliers ........................................ 17,734 18,769 

4232 ...................................................... Furniture and Home Furnishing Merchant Wholesalers ...................................... 11,353 11,844 

42362 .................................................... Electrical and Electronic Appliance, Television, and Radio Set Merchant 

Wholesalers.

2,444 2,591 

42391 .................................................... Sporting and Recreational Goods and Supplies Merchant Wholesalers ............ 5,019 5,196 

42392 .................................................... Toy and Hobby Goods and Supplies Merchant Wholesalers ............................. 2,227 2,302 

42394 .................................................... Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ... 7,363 7,447 

42399 .................................................... Other Miscellaneous Durable Goods Merchant Wholesalers .............................. 9,040 9,302 

42432 .................................................... Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers .................... 3,557 3,722 

42433 .................................................... Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers.6,797 7,029 

42434 .................................................... Footwear Merchant Wholesalers ......................................................................... 1,521 1,593 

42499 .................................................... Other Miscellaneous Nondurable Goods Merchant Wholesalers ........................ 11,203 11,490 

Total .............................................................................................................. 78,258 81,285 

Source: U.S. Department of Commerce, Bureau of the Census, 2008 County Business Patterns, Number of Firms, Number of Establishments, 

Employment, and Annual Payroll by Small Enterprise Employment Sizes for the United States, NAICS Sectors: 2008. (Available at: http:// 

www2.census.gov/econ/susb/data/2008/us_naicssector_small_emplsize_2008.xls, last accessed on 16 August 2011. 

In addition to the wholesalers 

tabulated in Table 3, the U.S. Census 

Bureau estimated that there were 

206,072 nonemployer businesses 

classified in NAICS categories that 

could include wholesalers of children’s 

products. Nonemployer businesses are 

generally very small sole 

proprietorships. The average receipts for 

the nonemployer business wholesalers 

were about $86,000.4 An unknown 

number of nonemployer wholesalers 

could import children’s products. 

3. Retailers 

Retailers that obtain their products 

from domestic manufacturers or 

wholesalers will not be directly 

impacted by the rule because the 

manufacturers or wholesalers would be 

responsible for the testing and 

certification of the products. However, 

there are some retailers that 

manufacture or directly import some 

products; and therefore, they will be 

responsible for ensuring that these 

products are properly tested and 

certified. The number of such retailers 

is not known. Table 4 shows the number 

of retailers by NAICS code that would 

cover most children’s products. 

According to SBA size standards, 

retailers are generally considered to be 

small entities if their annual sales are 

less than $7 million to $30 million, 

depending on the specific NAICS 

category. Because of the way in which 

the data were reported by the Bureau of 

the Census, the estimates of the number 

of small firms in each category in Table 

4 are based on similar, but different 

criteria. Although there are more than 

100,000 firms that would be considered 

‘‘small businesses’’ in these categories, 

it is not known how many of these firms 

are engaged in importing or 

manufacturing children’s products. 

Many firms probably obtain all of their 

products from domestic wholesalers or 

manufacturers and would not be 

directly impacted by the rule. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69527 

5U.S. Department of Commerce, Bureau of the 

Census, ‘‘Revised 2008 Nonemployer Statistics 

Table.’’ Available at: http://www.census.gov/econ/

nonemployer/

Revised%202008%20Data%20With%202009%20

Methodology%20Applied.xls (last accessed 16 

August 2011). 

TABLE 4—RETAILERS

NAICS Code Description 

SBA Size 

standard (millions of dollars 

of annual 

sales) 

Criteria used 

for estimate of 

small firms 

(millions of 

dollars of 

annual sales) 

Small 

firms 

Total 

firms 

441221 ................................ Motorcycle, ATV, and Personal Watercraft Dealers ...... < 30 < 25 4,794 4,879 

4421 .................................... Furniture Stores .............................................................. < 19 < 10 16,033 16,611 

44813 .................................. Children’s and Infant’s Clothing Stores .......................... < 30 < 25 2,057 2,074 

44814 .................................. Family Clothing Stores ................................................... < 25.5 < 25 6,588 6,684 

44815 .................................. Clothing Accessories Stores .......................................... < 14 < 10 2,757 2,774

44819 .................................. Other Clothing Stores ..................................................... < 19 < 10 6,331 6,393 

4482103 .............................. Children’s & Juveniles’ Shoe Stores .............................. < 25.5 < 25 227 230 

4482104 .............................. Family Shoe Stores ........................................................ < 25.5 < 25 2,905 2,941 

45111 .................................. Sporting goods stores .................................................... < 14 < 10 14,388 14,545 

45112 .................................. Hobby, toy, & game stores ............................................ < 25.5 < 25 4,612 4,629 

452 ...................................... General Merchandise Stores ......................................... < 30 < 25 6,873 6,971

45322 .................................. Gift, Novelty, and Souvenir Store .................................. < 30 < 25 19,297 19,339

454111 ................................ Electronic Shopping ....................................................... < 30 < 25 11,374 11,646 

454113 ................................ Mail Order Houses ......................................................... < 35.5 < 25 5,281 5,645 

4542 .................................... Vending machine operators ........................................... < 10 < 10 3,796 3,887

Total ........................................................................ ........................ ........................ 107.313 124,700 

Source: U.S. Census Bureau, 2007 Economic Census, Release date 11/02/2010. 

In addition to the retailers tabulated 

in Table 4, the U.S. Census Bureau 

estimated that there were 324,918 

nonemployer businesses classified in 

NAICS categories that could include 

retailers of children’s products. 

Nonemployer businesses are generally 

very small sole proprietorships. The 

average receipts for the nonemployer 

business retailers were about $40,000.5

An unknown number of nonemployer 

retailers could import children’s 

products. 

F. Compliance, Reporting, and 

Recordkeeping Requirements of Rule 

The final rule establishes some 

requirements for the certification of 

children’s products. It also establishes 

protocols and standards for ensuring 

that children’s products are subject to 

testing periodically, when there has 

been a material change in the product’s 

design or manufacturing process, 

including the sourcing of component 

parts, and for safeguarding against the 

exercise of undue influence on a third 

party conformity assessment body by a 

children’s product manufacturer or 

private labeler. The requirements are 

discussed in more detail below, and the 

impact that these could have on 

manufacturers is discussed in a later 

section of this preamble. 

The final rule will impact virtually all 

manufacturers and importers of 

children’s products because nearly all 

children’s products are subject to some 

children’s product safety rules. For 

example, the restrictions on lead 

content cover almost all children’s 

products. Even products that contain 

some of the materials that have been 

excluded from the restrictions (see 16 

CFR 1500.88) or that have been 

determined inherently not to contain 

lead in excess of the legal requirement 

(see 16 CFR 1500.91) might have to be 

tested for compliance with other rules. 

For example, although the fabric in 

wearing apparel might be excluded from 

the requirement to test for lead content, 

it may have to be tested for compliance 

with flammability requirements. Any 

other non-excluded objects on the 

apparel, such as buttons, snaps, zippers, 

or applique ́s will also need to be tested 

for lead content. 

In meeting the requirements of the 

final rule, manufacturers and importers 

can use component part testing, as 

provided by 16 CFR part 1109. This 

means, for example, that manufacturers 

could submit samples of paint that they 

are using on their products to a third 

party testing laboratory to be tested for 

lead and heavy metal content. This 

could reduce the amount of testing 

required because the results from the 

component part tests could be relied 

upon for demonstrating the compliance 

of all products on which that paint was 

used, rather than retesting the paint 

multiple times because it was used on 

multiple products. The final rule also 

allows manufacturers and importers to 

rely upon testing of component parts 

that was procured by their suppliers, 

provided that the testing meets all of the 

requirements in 16 CFR part 1109. The 

requirements include that the testing be 

performed by a third party conformity 

assessment body whose accreditation 

has been accepted by the CPSC. To rely 

upon component part testing—whether 

conducted by the children’s product 

manufacturer or by a supplier of the 

component part—there must be 

sufficient documentation so that the 

component part can be traced back to 

the party who procured the third party 

test results demonstrating that the 

component part complies with the 

applicable safety rules. Provisions in 16 

CFR part 1109 also allow an importer to 

rely upon testing procured by, or a 

certificate issued by, a supplier of a 

finished good in issuing their own 

certificate for a product. Therefore, if a 

foreign manufacturer has tested and 

certified a children’s product in 

accordance with the requirements of 16 

CFR part 1109, an importer may rely 

upon that testing or certification in 

issuing their own certificate for the 

product. 

G. Partial Exemption for Small Batch 

Manufacturers 

H.R. 2715, which was enacted on 

August 12, 2011, provides some relief 

for small batch manufacturers from the 

third party testing requirements 

contained in the final rule. H.R. 2715 

requires that we consider alternative 

requirements for small batch 

manufacturers. Until we determine what 

alternative requirements are suitable for 


emcdonald on DSK5VPTVN1PROD with RULES3
69528 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

small batch manufacturers, small batch 

manufacturers are not required to obtain 

third party testing results to confirm 

that their children’s products conform 

to several children’s product safety 

rules. However, small batch 

manufacturers are still subject to the 

third party testing requirements of the 

final rule with respect to the lead 

content of paint; full-size and non fullsize cribs; pacifiers; small parts; 

children’s metal jewelry; and baby 

bouncers, walkers, and jumpers. 

H.R. 2715 defines a ‘‘small batch 

manufacturer’’ as a manufacturer who 

had no more than $1 million in total 

gross revenue from sales of all consumer 

products in the previous calendar year 

(which will be adjusted annually by the 

percentage increase in the Consumer 

Price Index for all urban consumers). 

We will implement the small batch 

manufacturer provision of H.R. 2715 in 

a separate proceeding. 

H. Certification Tests 

To certify that a children’s product 

complies with all applicable children’s 

product safety rules, the final rule 

requires that manufacturers submit 

samples of the product to a third party 

conformity assessment body whose 

accreditation has been accepted by the 

CPSC. The final rule requires that the 

number of samples submitted must be 

sufficient to provide a high degree of 

assurance that the tests conducted for 

certification purposes accurately 

demonstrate the ability of the children’s 

product to meet all applicable children’s 

product safety rules. Fewer samples are 

needed if the manufacturing process 

consistently results in products that are 

uniform in composition and quality. 

More samples will be needed if there is 

more variability in the finished 

products. If any product fails 

certification testing, the manufacturer 

must investigate and address the cause 

of the failure, even if other samples 

passed the certification tests. 

The cost of the third party testing is 

discussed in more detail later in part 

IV.N. of the preamble. Manufacturers 

also may incur costs for any consultants 

to provide advice for determining the 

number of samples that should be 

submitted for testing and to ensure that 

it was in compliance with the 

requirements. There also will be some 

administrative and recordkeeping costs 

associated with this requirement. 

I. Periodic Third Party Testing 

The final rule requires manufacturers 

and importers of children’s products to 

periodically submit samples of their 

products to third party conformity 

assessment bodies whose accreditation 

has been accepted by the CPSC for 

testing to ensure their products continue 

to comply with all applicable children’s 

product safety rules. Manufacturers 

need to conduct periodic third party 

testing frequently enough to ensure, 

with a high degree of assurance, that the 

product continues to comply with all 

applicable children’s product safety 

rules, but in no case can the interval 

between periodic tests exceed the 

maximum periodic testing interval 

applicable to the manufacturer. 

Depending upon other testing 

procedures that a manufacturer may opt 

to use, one of three possible maximum 

periodic testing intervals will apply to 

a children’s product manufacturer. The 

first option applies to manufacturers 

who do not conduct other production 

testing of a children’s product. 

Manufacturers who do not undertake 

other production testing must conduct 

periodic third party testing of the 

product at least once a year. The final 

rule requires manufacturers to develop 

a periodic test plan that will ensure that 

the children’s products manufactured 

after the certification, or since the 

previous periodic testing was 

conducted, continue to comply with all 

applicable children’s product safety 

rules. The periodic test plan must 

include the tests to be conducted, the 

intervals at which the tests will be 

conducted, and the number of samples 

to be tested. Although the manufacturer 

has some discretion in determining the 

interval between periodic tests, the 

interval must be short enough to ensure 

that if the samples selected for periodic 

third party testing pass the tests, then 

there is a high degree of assurance that 

the untested products manufactured 

during the interval comply with all 

applicable children’s product safety 

rules; and the interval must be no longer 

than one year. 

The second option applies to 

manufacturers who implement a 

production testing plan (which can use 

first or third party testing). If a 

manufacturer has implemented a 

production testing plan that meets the 

requirement of § 1107.21(c) of the final 

rule, the manufacturer must conduct 

third party periodic testing at least once 

every two years. The production testing 

plan must describe the production 

management techniques and tests that 

must be performed to provide a high 

degree of assurance that products 

manufactured after certification 

continue to meet all applicable 

children’s product safety rules. The 

production testing plan must also 

include additional information, such as 

the intervals at which tests must be 

conducted or measurements will be 

made. The test methods used in the 

production testing plan need not be the 

same test methods used for certification, 

but they must be effective in 

determining compliance with the 

applicable children’s product safety 

rules. 

Manufacturers or importers who 

choose this second option, will need to 

ensure that their quality assurance or 

testing program meets the requirements 

of the final rule for production testing 

and that their testing program provides 

a high degree of assurance that all 

products manufactured or imported 

continue to comply with all applicable 

children’s product safety rules. In 

addition, at least once every two years, 

this option requires the manufacturer or 

importer to submit samples to a CPSCaccepted third party conformity 

assessment body to be tested for 

conformity with all applicable 

children’s product safety rules. The 

final rule does not specify how many 

samples must be submitted to the third 

party conformity assessment body, nor 

does it set forth what constitutes an 

appropriate periodic testing interval 

(other than stating it must not be greater 

than two years). However, the 

expectation is that this option will 

require less testing by third party 

conformity assessment bodies because, 

under this option, the (first party or 

third party) production testing provides 

the manufacturer or importer with a 

high degree of assurance that the 

products continue to comply with the 

applicable children’s product safety 

rules and can provide manufacturers 

with information that can be used to 

determine the interval and number of 

samples required for the periodic third 

party testing. 

The third option applies to 

manufacturers who conduct testing to 

ensure continuing compliance with the 

applicable children’s product safety 

rules using a testing laboratory 

accredited to ISO/IEC 17025:2005, 

General requirements for the 

competence of testing and calibration 

laboratories, but whose accreditation 

has not been accepted by the CPSC. In 

most cases, these will be in-house 

testing laboratories. If a manufacturer 

conducts testing using such a testing 

laboratory, the manufacturer must 

conduct periodic third party testing at 

least once every three years. Any testing 

laboratory used under this option must 

be accredited by an accreditation body 

that is accredited to ISO/IEC 

17011:2004, Conformity assessment— 

General requirements for accrediting 

conformity assessment bodies. The tests 

used under this option must be the same 

tests used for certification to the 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69529 

applicable children’s product safety 

rules. The testing must be conducted 

frequently enough to provide a high 

degree of assurance that the product 

continues to comply with all applicable 

children’s product safety rules. 

The final rule does not specify how 

many samples a manufacturer using the 

third option must submit to the third 

party conformity assessment body, nor 

does it set forth what constitutes an 

appropriate periodic testing interval 

(other than stating it must not be greater 

than three years). However, as with the 

second option, the intent behind 

including this option in the final rule is 

to reduce the cost that the rule imposes 

on children’s product manufacturers, by 

reducing the amount of testing that they 

must obtain from third party conformity 

assessment bodies. The testing that the 

manufacturer performs in an ISO/IEC 

17025:2005-accredited testing laboratory 

provides the high degree of assurance 

that the products comply with the 

applicable children’s product safety 

rules, and it also can provide 

manufacturers with information that can 

be used to determine interval and 

number of samples required for the 

periodic third party testing. 

Like the second option, the intent of 

the third option is to reduce the final 

rule’s cost to manufacturers, by 

reducing the amount of testing that they 

must conduct using third party 

conformity assessment bodies. However, 

the manufacturers that are most likely to 

benefit from this third option are 

manufacturers who have their own inhouse ISO/IEC 17025:2005-accredited 

testing laboratories. These are likely to 

be larger manufacturers, so this option 

is not expected to provide much relief 

to smaller manufacturers. To the extent 

that the smaller manufacturers compete 

with the larger manufacturers, this 

option may adversely affect the 

competitiveness of the smaller 

manufacturers relative to larger 

manufacturers because any cost 

reduction will disproportionately 

benefit larger manufacturers. 

Under all periodic testing options, a 

manufacturer may need statistical or 

other knowledge in order to develop 

their testing plans, including 

determining the appropriate testing 

intervals and number of samples 

required to provide the manufacturer 

with a high degree of assurance that its 

children’s products are in compliance 

with all applicable children’s product 

safety rules. If these services are not 

available in-house, the firm may have to 

hire outside consultants. Additionally, 

firms will incur administrative and 

recordkeeping costs associated with the 

periodic testing requirement, in 

addition to the cost of the third party 

testing, which is described in more 

detail later in this analysis. 

J. Third Party Testing Due to Material 

Changes 

If a children’s product undergoes a 

material change in product design or 

manufacturing processes, including the 

sourcing of component parts that could 

affect the product’s ability to comply 

with the applicable children’s product 

safety rules, the final rule requires the 

manufacturer to submit samples of the 

materially changed product to a third 

party conformity assessment body for 

testing. The number of samples must be 

sufficient to provide a high degree of 

assurance that the materially changed 

product complies with all applicable 

children’s product safety rules. The 

testing can be limited to the portion or 

component part of the finished product 

that was changed and for compliance 

with those children’s product safety 

rules for which compliance might have 

been affected. 

The primary cost of this requirement 

will be the cost of the third party 

testing. There also will be some 

administrative and recordkeeping costs 

associated with this requirement. The 

professional skills required by the 

manufacturer are the same skills 

required for the initial certification and 

periodic tests. 

K. Protection Against Undue Influence 

The final rule requires that each 

manufacturer of children’s products 

establish procedures to safeguard 

against the exercise of undue influence 

by a manufacturer on a third party 

conformity assessment body. At a 

minimum, these procedures must 

include written policy statements from 

company officials that the exercise of 

undue influence is not acceptable and 

directing that every appropriate staff 

member receives training on avoiding 

undue influence and signs a statement 

attesting to their participation in the 

training. The procedures also must 

include a requirement to retrain the 

appropriate staff if there are substantive 

changes in the requirements for 

safeguarding against the exercise of 

undue influence. The training 

procedures must include a requirement 

to notify us immediately of any attempt 

by the manufacturer to hide or exert 

undue influence over test results, and a 

requirement to inform employees that 

allegations of undue influence may be 

reported confidentially to us and to 

describe how such a report can be made. 

Firms will incur some costs in 

establishing the safeguards against 

undue influence. Although several 

commenters stated that establishing 

these safeguards would be burdensome, 

none provided estimates of what the 

cost would be. The final rule gives firms 

great flexibility in meeting these 

requirements. For example, the final 

rule does not prescribe the form of the 

training, and firms may include this 

training along with other types of 

employee training. 

L. Recordkeeping 

The final rule requires manufacturers 

of children’s products to keep the 

following records: 

• A copy of the Children’s Product 

Certificate for each product. The 

children’s product covered by the 

certificate must be clearly identifiable 

and distinguishable from other 

products; 

• Records of each certification test. 

The manufacturer must have separate 

certification test records for each 

manufacturing site; 

• Records of one of the following for 

periodic tests of a children’s product: 

Æ Periodic test plan and periodic test 

results; 

Æ Production testing plan, production 

test results, and periodic test results; or 

Æ Testing results of tests conducted 

by a testing laboratory accredited to 

ISO/IEC 17025:2005 and periodic test 

results. 

• Records of descriptions of all 

material changes in product design, 

manufacturing processes, and sourcing 

of component parts, the certification 

tests, the test results, and the actual 

values of the tests, if any; and 

• Records of the undue influence 

procedures, including training materials 

and training records of all employees 

trained on these procedures. 

These records must be maintained for 

five years. The records must be made 

available for inspection by the CPSC, 

upon request. The records may be 

maintained in languages other than 

English, if the records can be provided 

immediately to us and translated 

accurately into English within 48 hours 

of a request by the CPSC or a longer 

period, as negotiated with CPSC staff. 

We have estimated that, on average, it 

will take three to five hours for 

recordkeeping per product. However, 

the time needed for recordkeeping for 

any particular product could be 

substantially higher or lower. For 

example, recordkeeping for products 

that are subject to multiple standards, or 

products that require a substantial 

amount of testing, could need 

substantially more hours. For other 

products, such as those subject to only 

one standard, and for which little 


emcdonald on DSK5VPTVN1PROD with RULES3
69530 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

testing is required, the number of hours 

needed for recordkeeping might be less. 

M. Consumer Product Labeling Program 

The final rule establishes a program 

by which any manufacturer or private 

labeler of a consumer product may label 

product as complying with the 

applicable certification requirements for 

the product. If the manufacturer has 

certified that a consumer product 

complies with all applicable consumer 

product safety rules, the manufacturer 

or private labeler may affix a label to the 

product which states that the product: 

‘‘Meets CPSC Safety Requirements.’’ The 

label must be visible and legible. This 

program is voluntary in that 

manufacturers and private labelers are 

not required to affix this label to their 

products. However, opting not to affix 

the label to the product would not 

relieve the firm of its responsibility to 

ensure that the products comply with 

the applicable safety rules and with all 

other provisions of the rule. This 

provision is not expected to have a 

significant impact on firms, however, 

because the program is voluntary, and 

the costs of adding or modifying a label 

on a product are expected to be low. 

N. Cost of Third Party Testing and 

Potential Impact of the Rule 

The costs of the third party testing 

requirements are expected to be 

significant for some manufacturers and 

are expected to have a disproportionate 

impact on small and low-volume 

manufacturers. This section discusses 

the cost of third party testing and the 

potential impact of the third party 

testing and other requirements of the 

final rule on manufacturers. 

1. Cost of Third Party Testing 

The cost of third party testing is 

influenced by many factors, including 

the amount and skill of the labor 

required to conduct the tests, the cost of 

the equipment involved, the cost of 

transporting the product samples to the 

test facility, and the geographic area 

where the tests are conducted. Some 

tests require a substantial amount of 

time to conduct the tests, including the 

preparation of the samples. It might take 

a couple of days, for example, to test a 

bicycle for compliance with the bicycle 

standard (16 CFR part 1512). Similarly, 

a chemist testing the lead content of a 

product might be able to test only a few 

metal component parts per day, due to 

the amount of time required to prepare 

the samples and clean and calibrate the 

equipment between tests. 

It should be noted that the price that 

a given manufacturer pays for testing is 

often the result of negotiations between 

the testing laboratory and the 

manufacturer. Manufacturers who do a 

large volume of business with a testing 

laboratory frequently can obtain 

discounts on the testing laboratory’s 

normal charges; but manufacturers who 

do only a small volume of business may 

not be able to negotiate a discount on 

the testing. 

Information on the cost of third party 

testing to determine compliance with 

some children’s product safety rules is 

provided below. The information was 

collected from a number of sources, 

including published price lists from 

some testing laboratories, conversations 

with representatives of testing 

laboratories, actual invoices provided by 

consumer product manufacturers, and 

public comments we received. The data 

are not based upon a statistically valid 

survey of testing laboratories. 

Additionally, the costs include only the 

costs that would be charged by the 

testing laboratory. Not included in the 

information are the costs of the samples 

consumed in destructive tests, the cost 

of shipping the samples to the testing 

laboratories, and any related 

administrative or recordkeeping 

activity. According to one commenter, 

these costs could add 15 to 50 percent 

to the third party testing costs. 

2. Lead Content and Lead-in-Paint 

The cost per component part for 

testing lead content and lead-in-paint 

using inductive coupled plasma (ICP) 

analysis will range from a low of about 

$20 per test, to more than $100 per test. 

The lowest per-unit cost represents a 

substantially discounted price charged 

to a particular customer by a testing 

laboratory in China, and therefore, the 

price might not be typical. Within the 

United States, typical prices range from 

around $50, to more than $100 per test. 

The cost of testing for lead content 

using X–Ray fluorescence (XRF) 

technology is significantly less 

expensive. Some firms have offered to 

screen products for lead content for as 

little as $2 per test. These offers are 

generally directed to stores or 

businesses that want to check their 

inventory for conformity with the 

retroactive lead content requirements 

contained in the CPSIA. Some testing 

laboratories will charge for XRF testing 

at an hourly rate, which can cost around 

$100. Ten to 30 tests can be conducted 

in an hour. 

We have approved XRF test methods 

for determining the lead content of 

homogenous polymer products. 

Assuming that 10 to 30 tests can be 

conducted in an hour at a rate of $100 

per hour, the cost of XRF testing for 

homogenous polymer products would 

be between $3 and $10 per test. 

For testing the lead content of paint, 

we have approved the use of a specific 

XRF test method described in ASTM 

F2853 that uses energy dispersive XRF 

using multiple monochromatic beams. 

Generally, fewer tests can be conducted 

in an hour using this test method. If 6 

to 12 tests can be conducted in an hour 

at a rate of $100 an hour, then the cost 

of testing a paint for lead content using 

the approved XRF technique would be 

about $8 to $17. 

Other than for homogenous polymer 

components and the lead content of 

paint, we have not approved the use of 

XRF techniques for testing any other 

materials. For other materials, such as 

metal components, manufacturers will 

need to use ICP analyses techniques to 

test for lead content. 

3. Phthalates 

The cost of testing for phthalate 

content will range from around $100 (a 

discounted price by a testing laboratory 

in China) to about $350. These are the 

costs per component part, and they 

include testing for all six of the 

individual phthalates whose content is 

restricted. 

4. Bicycle Standard (16 CFR part 1503) 

According to one testing laboratory, it 

takes one to two days to test a bicycle. 

The estimated price for testing one 

bicycle may range from around $700, if 

the testing is performed in China, to 

around $1,100, if the testing is 

performed in the United States. A 

manufacturer who needs several models 

of bicycles tested at the same time, 

might be able to obtain discounts on 

these prices. This does not include 

testing for lead or phthalates in 

nonmetal component parts. H.R. 2715, 

however, exempted the metal 

components of bicycles from the third 

party testing requirements for lead 

content. 

5. Bicycle Helmets 

One testing laboratory quoted a price 

of $600 for testing one model of a 

bicycle helmet to the CPSC bicycle 

helmet standard. A price list from 

another testing laboratory stated that 

conducting the certification testing to 

the Snell Foundation’s bicycle helmet 

standard, which is similar to the CPSC 

standard, is $830. 

6. Full-Size Cribs 

As with bicycles, testing cribs 

requires a substantial amount of labor 

time to assemble the crib, take the 

appropriate measurements, and perform 

the required tests. The cost of testing a 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69531 

full-size crib to the pre-2010 standard 

was about $750 to $1,200 for testing 

performed in the United States. The cost 

of testing a full-size crib to the current 

standard may be somewhat higher. The 

cost can vary, depending on the features 

of the individual cribs that require 

testing and among the various testing 

laboratories. Some manufacturers might 

receive discounted prices. This does not 

include testing the crib for lead and 

phthalates, which, to the extent 

necessary, would add to the cost of 

testing a crib to all applicable safety 

rules. 

7. Toys 

The children’s product safety rules 

applicable to toys, including the ASTM 

F963 standard made mandatory by the 

CPSIA, include a wide variety tests, 

including tests for soluble heavy metals 

in surface coatings and for various 

physical and mechanical criteria. Based 

on the itemized prices on several 

invoices provided to us by testing 

laboratories or otherwise made public, 

the cost of the physical and mechanical 

tests range from about $50 to $245. The 

cost of the chemical test for the presence 

of heavy metals ranges from about $60 

to $190 per surface coating. Again, these 

costs do not include testing for lead and 

phthalates, which add to the total cost. 

The flammability requirements of 

ASTM F963 were not made mandatory 

by the CPSIA, but we were directed to 

examine the flammability requirements 

and consider promulgating rules 

addressing the issue. If some 

flammability tests are eventually 

required, the cost per test could be in 

the range of $20 to $50, based on some 

observed costs for the ASTM F963 

flammability tests. 

8. Cost of Third Party Testing by 

Product 

The cost to obtain the required third 

party testing for a product depends on 

the types and number of tests that must 

be performed, as well as the number of 

samples that are required to provide a 

high degree of assurance that the tests 

conducted for certification purposes 

accurately demonstrate the ability of the 

product to meet the applicable 

children’s product safety rules or ensure 

continuing compliance with the 

applicable children’s product safety 

rules. The cost of the testing also will be 

affected by the extent to which the 

manufacturer can use component part 

testing. Because of the wide variety of 

manufacturers and products that would 

be affected by the rule, we cannot 

provide comprehensive estimates of the 

impact of the rule on all manufacturers 

or products. The discussion below is 

intended to provide only some 

perspective on the potential impact. 

9. Number of Samples Required 

The final rule does not specify the 

exact number of samples that must be 

submitted to third party conformity 

assessment bodies, nor does it specify 

the testing interval, other than to 

provide maximum intervals. Instead, the 

final rule requires manufacturers to 

determine the number samples and the 

necessary testing interval based on 

factors such as: The variability of the 

product, manufacturing processes, and 

information obtained from other testing. 

However, it is likely that between 

certification testing, testing after a 

material change, and periodic testing, 

many manufacturers will need to submit 

more than one sample of a given 

product to third party conformity 

assessment bodies during a given year. 

Because some children’s product safety 

rules require more than one unit of the 

product to complete all of the required 

tests, one sample may consist of 

multiple units of the product. 

For purposes of certifying a children’s 

product (including testing after a 

material change), the final rule requires 

manufacturers to submit enough 

samples to a third party conformity 

assessment body to provide a high 

degree of assurance that tests conducted 

for certification purposes accurately 

demonstrate the ability of the product to 

comply with all applicable children’s 

product safety rules. In determining 

how many samples to submit, a 

manufacturer is to consider the 

variability in the product and 

manufacturing processes. If the 

manufacturing process for a children’s 

product consistently creates finished 

products that are uniform in 

composition and quality, such as with 

die casting, a manufacturer may be able 

to submit a relatively small number of 

samples to the third party conformity 

assessment body. If the manufacturing 

process for a children’s product results 

in variability in the composition or 

quality of children’s products, such as 

what might be expected with hand 

assembly, a manufacturer may need to 

submit a greater number of samples. 

For periodic testing, the final rule 

requires that the number of samples 

selected must be sufficient to assess— 

with a high degree of assurance—the 

continuing compliance of the children’s 

product with all applicable safety rules. 

Additionally, the testing interval for 

periodic testing must be short enough to 

ensure that, if the samples selected for 

periodic testing pass the test, there is a 

high degree of assurance that the other 

untested children’s products 

manufactured during the interval 

comply with the applicable children’s 

product safety rules. Manufacturers who 

have implemented a production testing 

plan or test in an ISO/IEC 17025:2005- 

accredited testing laboratory may 

consider the information obtained from 

the testing in determining the testing 

interval and the number of samples that 

are needed. 

10. Hypothetical Toy Testing Example 

To provide some information on what 

the magnitude of the third party testing 

costs may be for some manufacturers of 

children’s products, this section 

discusses the potential cost of obtaining 

third party testing for a hypothetical toy. 

This example is hypothetical and is 

intended to illustrate some potential 

cost implications of the rule. The 

example is not intended be 

representative of every product or 

manufacturer. The costs per test that are 

assumed in the examples are based on 

the cost of tests discussed above; but the 

actual costs can vary significantly 

between conformity assessment bodies. 

The testing costs for any particular 

manufacturer also depend upon factors 

such as the complexity of the products, 

the variation in the materials used, 

manufacturing processes used, 

opportunities to use component part 

testing, and so on. We used a similar 

example in the initial regulatory 

flexibility analysis. The discussion has 

been changed to reflect the fact that 

energy dispersive XRF analysis can be 

used to test for lead in paint in addition 

to XRF testing in homogenous polymer 

products. We also have modified the 

discussion to deemphasize references to 

statistical measurements because, 

although statistical measurements might 

be useful, the number of samples that 

must be tested need not be one that 

provides a particular confidence level, 

such as 95 percent confidence level that 

all products in a lot are compliant. 

Toys must meet requirements 

concerning lead and phthalate content, 

as well as several physical and 

mechanical requirements, including the 

requirements of ASTM F963, which was 

made a mandatory standard by the 

CPSIA. In this example, we assume that 

the testing costs are at the low to middle 

part of the ranges discussed above, and 

we also assume that the hypothetical toy 

contains one metal component part that 

must be tested for lead content using 

ICP analysis (at $50) and two plastic 

component parts for which XRF 

analysis can be used for determining the 

lead content (two tests at $6 each). The 

plastic component parts also must be 

tested for phthalate content (two tests at 

$225 each). Additionally, we assume 


emcdonald on DSK5VPTVN1PROD with RULES3
69532 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

6OSHA, Assigned Protection Factors, Final Rule, 

Federal Register (71 FR 50121–50192), 24 August 

2006. 

7Retail sales of toys in the United States are about 

$22 billion per year (Toy Industry Association press 

release dated 27 June 2011). A representative of the 

Toy Industry Association estimated that there are 

about 3 billion individual toys sold annually in the 

United States. This suggests an average retail price 

of $7 to $8 ($22 billion x 3 billion). 

that the toy contains four different 

paints that must be tested for both lead 

content ($13/test, assuming energy 

dispersive XRF analysis) and soluble 

heavy metals ($125/test). Finally, we 

assume that the toy is subject to some 

mechanical requirements that include 

use and abuse testing ($50 per test). 

Thus, the cost of testing the 

hypothetical toy for compliance to each 

applicable rule one time would be 

$1,114: $1,064 is associated with the 

chemical (lead, heavy metal, and 

phthalate) testing, and $50 is associated 

with the mechanical testing (including 

use and abuse testing). 

Having one sample tested by a third 

party conformity assessment body will 

probably not be sufficient to meet the 

requirements of the final rule. 

Therefore, the cost of the third party 

testing for the manufacturer of this 

hypothetical toy would be greater than 

$1,114. For example, if four samples are 

needed, the cost would be $4,456. The 

cost would be higher if some tests had 

to be conducted more than four times to 

provide the required high degree of 

assurance. The manufacturer might be 

able to reduce the third party testing 

costs if it is able to use component part 

testing for the chemical content tests. 

For example, if the plastic resins, metal 

component part, and paints are used on 

other products, the manufacturer could 

test the component parts independently 

of the individual finished products and 

spread the cost of the chemical content 

tests over more than one finished 

product. If the average cost of the 

chemical content tests could be reduced 

by a factor of four through component 

part testing, then the cost of testing the 

toy in this example for conformity with 

all applicable safety rules one time 

would be $316 (cost of chemical testing 

of $1,064/4 and cost of the mechanical 

and use and abuse testing of $50). 

However, the cost of third party testing 

for the manufacturer would likely be 

higher because testing one sample will 

seldom be sufficient to provide the 

required high degree of assurance. For 

example, if each component part 

required four tests, and the mechanical 

testing required must be repeated four 

times to provide the required high 

degree of assurance, then the cost of the 

third party testing for the hypothetical 

toy would be $1,264. 

11. Impact of Final Rule on Firms 

Whether the third party testing costs 

would have a substantial adverse impact 

on a firm depends upon the individual 

circumstances of the firm. One factor is 

the magnitude of the impact in relation 

to the revenue of the firm. A typical 

profit rate is about five percent of 

revenue. In other words, for every one 

dollar of revenue, only five cents might 

remain after paying all expenses. 

Therefore, a new cost that amounted to 

one percent of revenue could, all other 

things equal, reduce the profit by 20 

percent and would be considered to be 

a significant impact by most firms. This 

would be consistent with what some 

other agencies consider to be significant. 

The Occupational Safety and Health 

Administration (OSHA), for example, 

considers an impact to be significant if 

the costs exceed 1 percent of revenue or 

5 percent of profit.6

Some insight on the disparate impact 

that the final rule could have on small 

businesses can be provided by 

examining how the rule might impact 

three hypothetical toy manufacturers of 

different sizes. The costs associated 

with third party testing that the 

hypothetical manufacturers would face 

will be described, and the potential 

impact on the hypothetical 

manufacturers will be discussed. This 

discussion is summarized in Table 5. 

TABLE 5—IMPACT OF RULE ON THREE HYPOTHETICAL FIRMS

Hypothetical 

firm A—large 

manufacturer 

Hypothetical 

firm B—small 

manufacturer 

Hypothetical 

firm C—small 

batch 

manufacturer 

1 .............................. Number of Different Products ................................................................. 1,000 100 10 

2 .............................. Annual Production Volume per Product ................................................. 100,000 10,000 1,000 

3 .............................. Total Annual Production Volume (Row 1 × Row 2) ............................... 100,000,000 1,000,000 10,000 

4 .............................. Revenue per unit sold ............................................................................ $4 $4 $4 

5 .............................. Total Annual Revenue (Row 4 × Row 3) ............................................... $400,000,000 $4,000,000 $40,000 

6 .............................. Cost of testing each product for compliance with all rule once ............. $1,114 $1,114 $102 

7 .............................. Cost of Testing Each Product 4 Times (Row 6 × 4) .............................. $4,456 $4,456 $408 

8 .............................. Total Third Party Testing Cost (Row 7 × Row 1) ................................... $4,456,000 $445,600 $4,080 

9 .............................. Cost of Samples (4 samples of 2 units of each product) ...................... $32,000 $3,200 $320 

10 ............................ Recordkeeping (5 hours/product at $36.43/hour) .................................. $182,150 $18,215 $1,822 

11 ............................ Total Testing Cost for One Year (Sum of Rows 8 through 10) ............. $4,670,150 $467,015 $6,222

12 ............................ Testing Cost as Percent of Revenue (Row 11/Row 5) .......................... 1.2% 11.7% 15.6% 

12. Three Hypothetical Manufacturers 

The first hypothetical manufacturer, 

Firm A, is a large toy manufacturer that 

offers 1,000 different toys with an 

annual production or sales volume of 

100,000 units each. Its total annual 

production volume is then 100 million 

units (1,000 products × 100,000 units 

each), which is shown in Row 3 of Table 

5. The second hypothetical 

manufacturer, Firm B, is a smaller toy 

manufacturer offers 100 different 

products with an annual production or 

sales volume of 10,000 units each. 

Finally, the third hypothetical toy 

manufacturer is a small batch 

manufacturer that offers only 10 

products that with an annual 

production or sales volume of about 

1,000 units each. 

13. Revenue 

The average price of a toy is $7 to $8.7

However, because the retailer and any 

wholesalers or distributors would also 

get a share of the revenue, the 

manufacturer would be expected to get 

a fraction of the retail price. Therefore, 

the revenue received by a manufacturer 

of a toy that retails for $7 to $8 might 

be about $4 per unit. For some toys, the 

revenue per unit received by the 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69533 

8This is based on the assumption that about half 

the labor is management or professional and the 

other half is sales or office labor. For all workers 

in private industry, the total hourly compensation 

for management, professional, and related 

occupations is $50.08 and $22.78 office and 

administrative occupations (Bureau of Labor 

Statistics, Employer Cost for Employee 

Compensations, March, 2011). 

manufacturer might be lower, and for 

others it might be higher. To begin the 

example, we assume that the average 

revenue is $4 per unit. The Total 

Annual Revenue of the Firm (Row 5) is 

found by multiplying the Revenue per 

unit (Row 4) by the Total Annual 

Production Volume (Row 3). 

14. Third Party Testing Costs 

The final rule requires manufacturers 

to have children’s products tested by a 

third party conformity assessment body 

before the products are distributed, 

periodically after that, and when there 

has been a material change in the 

product. In these hypothetical 

examples, we assume that the 

manufacturers must submit samples of 

their products to third party conformity 

assessment bodies annually, whether for 

initial certification of products, periodic 

testing, or recertification after a material 

change. 

The cost of the third party testing for 

a toy is a function of the characteristics 

of the toy, such as the number and type 

of component parts, the materials used 

in its construction, and the specific toy 

standards and tests that apply to it. The 

cost of third party tests would not be 

expected to be affected by the size of the 

manufacturer (although some 

conformity assessment bodies might 

offer discounts to firms for whom they 

conduct a lot of testing). In the 

hypothetical example, we assume that 

the conformity assessment bodies will 

charge the manufacturer $1,114 to test 

the toy for conformance with each 

applicable children’s product safety rule 

(Row 6), which is the same cost used in 

the earlier discussion of the cost to test 

a hypothetical toy. In the case of Firm 

C, a small batch manufacturer, the third 

party testing costs may be lower. Unless 

we establish alternate requirements for 

small batch manufacturers, H.R. 2715 

may effectively exempt the qualifying 

products of small batch manufacturers 

from many third party testing 

requirements, including the 

requirements for phthalates, heavy 

metal content of paints, and the lead 

content of substrates (but not from other 

requirements, such as lead-in-paint or 

children’s metal jewelry). In the case of 

the toy example, Firm C will need to 

have the paints used tested for lead 

content and the toys themselves tested 

for small parts. Using the costs assumed 

in the hypothetical toy example, the 

cost to Firm C for testing each product 

once to the two applicable requirements 

would be $102 (4 paints at $13 each and 

for small parts at $50). 

This hypothetical example assumes 

that it is necessary to conduct each 

applicable test four times to provide the 

manufacturer with the necessary high 

degree of assurance, whether for the 

initial certification of the product, or to 

meet the periodic testing requirement. 

Therefore, the total cost that the 

manufacturer will be charged by a third 

party conformity assessment body is 

$4,456 per product for Firms A and B, 

and $408 per product for Firm C (Row 

7). Because each manufacturer produces 

more than one product, total third party 

testing costs (Row 8) is equal to the cost 

per product times the number of 

products produced multiplied by the 

number of products produced (Row 7 × 

Row 1). 

In this hypothetical example, we 

further assume that, to conduct each test 

at least once, the manufacturer must 

submit two units of the toy to the 

conformity assessment body. In other 

words, a sample consists of two units of 

the product. The cost of the samples 

consumed by testing is the revenue that 

the manufacturer forgoes because the 

units were used for testing and not sold. 

Therefore, the cost of the samples 

consumed in the testing (given in Row 

9) is calculated as the product of the 8 

units required to conduct the tests, the 

revenue per product, and the number of 

different products (i.e., 8 × Row 4 × Row 

1). 

Although component part testing has 

the potential to reduce third party 

testing costs, component part testing is 

not considered initially in these 

examples. One reason we did not 

consider it is that it has not been 

determined how extensively component 

part testing will be used in practice. 

Component part testing generally might 

not be an option for component parts 

that are not used in multiple products, 

or for which only a small portion of the 

production is used in children’s 

products. It also might not be applicable 

to some importers or manufacturers who 

obtain products from suppliers that do 

not have the capability for component 

part testing, or for which the 

manufacturer or importer, exercising 

due care, has not yet developed the 

degree of confidence in the supplier to 

rely upon test reports and records 

provided by the supplier. 

15. Recordkeeping 

Firms will incur costs for preparing 

and maintaining the records and 

documentation required by the final 

rule. In this example, we assume that 

the recordkeeping will require 

approximately five hours per toy. 

Assuming that the total compensation, 

per hour, for the employees involved in 

the recordkeeping is $36.43,8 the 

recordkeeping cost would be about $182 

per product. The total recordkeeping 

burden (given in Row 10) is the cost per 

product ($182), multiplied by the 

number of products (Row 1). This 

estimate of the recordkeeping burden 

assumes that the manufacturer will not 

be required to acquire any additional 

equipment or software to comply with 

the recordkeeping requirements of the 

final rule. 

16. Total Testing Cost 

The total cost of testing for one year 

is the sum of the cost of the third party 

testing, the cost of the samples 

consumed in the testing, the cost of the 

recordkeeping, and the cost of 

developing the sampling plans. This is 

given in Row 11 of Table 5. 

Manufacturers may incur other costs 

that were not considered above. For 

example, the proposed rule contained 

provisions requiring manufacturers to 

select the samples for periodic testing, 

using techniques that would result in a 

statistical simple random sample. There 

will likely be costs associated with such 

requirements. These potential costs 

include: The cost of hiring consultants 

to design a sampling plan for selecting 

a sample that meets established 

requirements and the cost of the added 

time and effort that might be required in 

selecting such a sample. However, H.R. 

2715 revised section 14(i)(2)(B)(ii) of the 

CPSIA by replacing the phrase: ‘‘the 

testing of random samples to ensure 

continued compliance’’ with the phrase: 

‘‘the testing of representative samples to 

ensure continued compliance.’’ Because 

of this change in the statute, we are not 

finalizing the section of the proposed 

rule pertaining to random samples. 

These costs will be addressed in more 

detail when we consider how to 

implement section 14(i)(2)(B)(ii) of the 

CPSA, as amended by the CPSIA and 

H.R. 2715. 

17. Impact on Hypothetical Firms 

The impact of the testing costs on 

each of the hypothetical firms is 

summarized in Row 12 of Table 5. For 

the large manufacturer, Firm A, the 

testing costs could amount to 1.2 

percent of the firm’s revenue (total 

testing cost, divided by the total 

revenue) if the firm received about $4 

per product. This could be considered a 


emcdonald on DSK5VPTVN1PROD with RULES3
69534 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

significant impact. (A typical profit is 

about 5 percent of total revenue. Thus, 

a 1.2 percent increase in costs could 

decrease profit for a typical firm by 24 

percent.) If the average revenue that this 

firm received is somewhat higher, 

however, the impact probably would 

not be considered significant. 

For Hypothetical Firm B, a smaller 

manufacturer, the testing costs would 

amount to about 11.8 percent of the 

firm’s revenue, if the firm received an 

average of $4 for each unit produced. 

For the small batch manufacturer, Firm 

C, the testing costs would amount to 

about 15.6 percent of its revenue. In 

both cases (i.e., Firms B and C), costs 

amounting to 11.8 percent and 15.6 

percent, respectively, of revenue would 

be considered a significant impact. 

These hypothetical examples illustrate 

the disproportionate impact that the 

final rule may have on small businesses. 

As illustrated, the final rule could also 

have a significant impact on even a large 

manufacturer. The significance of the 

impact increases as the production or 

sales volume of the manufacturer 

decreases. 

The example of Firm C can be used 

to demonstrate the relief that H.R. 2715 

may be able to provide to small batch 

manufacturers. If Firm C is unable to 

benefit from the testing exemptions 

provided by H.R. 2715, then Firm C 

would have faced the same per-unit 

testing costs as the other firms in this 

example: $1,114 instead of $102. Under 

that scenario, the total testing cost for 

Firm C would have been more than 

$46,000, which would have exceeded its 

revenue of $40,000. 

Some small manufacturers probably 

have average revenues per product that 

exceed $4. This might be the case 

especially if it is a specialty or niche 

market, in which only a few 

manufacturers participate, or if the 

product requires a substantial amount of 

skilled labor to create. Table 6 shows 

what the impact would be on Firm C, 

the hypothetical small batch 

manufacturer, if it received an average 

of $50 per unit for each unit it sold. Its 

total revenue would increase to 

$500,000 per year. The cost of the 

samples consumed in testing would 

increase to $4,000 (Row 9), which 

would increase the cost of testing to 

$9,902 (Row 11). The testing costs 

would amount to about 1.9 percent of 

the firm’s revenue, which might be 

considered significant, but it is much 

lower than it would have been if its 

revenue per unit was lower. It should be 

noted that if the manufacturer receives 

$50 per unit sold of a product, the retail 

price is likely substantially higher 

(unless the manufacturer sells a 

substantial portion of the product 

directly to the final consumer). 

TABLE 6—IMPACT ON HYPOTHETICAL FIRM C IF REVENUE PER UNIT IS $50 

Hypothetical 

firm C—very 

small 

manufacturer 

1 ............................. Number of Different Products ......................................................................................................................... 10 

2 ............................. Annual Production Volume per Product .......................................................................................................... 1,000 

3 ............................. Total Annual Production Volume (Row 1 × Row 2) ........................................................................................ 10,000 

4 ............................. Revenue per unit sold ..................................................................................................................................... $50 

5 ............................. Total Annual Revenue (Row 4 × Row 3) ........................................................................................................ $500,000 

6 ............................. Cost of testing each product for compliance with all rule once ...................................................................... $102 

7 ............................. Cost of Testing Each Product 4 Times (Row 6 × 4) ...................................................................................... $408 

8 ............................. Total Third Party Testing Cost (Row 7 × Row 1) ........................................................................................... $4,080 

9 ............................. Cost of Samples (4 samples of 2 units of each product) ............................................................................... $4,000 

10 ........................... Recordkeeping (5 hours/product at $36.43/hour) ........................................................................................... $1,822 

11 ........................... Total Testing Cost for One Year (Sum of Rows 8 through 11) ...................................................................... $9,902 

12 ........................... Testing Cost as Percent of Revenue (Row 12/Row 5) .................................................................................. 1.9% 

There also will be other costs that 

could be associated with the rule for 

which no quantification was attempted 

in the above hypothetical examples. 

One cost that was not considered is the 

additional administrative costs that are 

likely associated with the final rule’s 

requirements; these include the cost of 

tracking when each product or 

component part needs to be tested. It 

also includes the cost of monitoring the 

suppliers and component parts that are 

used, the production techniques used, 

and any changes in product design to 

determine when products need to be 

tested due to material changes. There 

also may be administrative costs in 

matching up test reports to finished 

goods and giving the approval to ship 

products that the manufacturer has 

certified. 

Another cost that could impact 

manufacturers for which quantification 

was not attempted is the cost of 

receiving test reports that indicate 

inaccurately that the product did not 

comply with a children’s product safety 

rule. When a manufacturer receives a 

test report that indicates inaccurately 

that a product does not meet a standard, 

the manufacturer could assume that the 

test was accurate and needlessly dispose 

of, or attempt to rework, the products 

covered by the test result; or, it might 

suspect that the test report was 

inaccurate and investigate the reason for 

the test failure. This could involve 

retesting samples of the product by 

other conformity assessment bodies and 

having the conformity assessment body 

that produced the inaccurate result 

attempt to determine if any error was 

made in testing the product. In any case, 

this could result in delays in shipping 

product and lost sales. 

Component part testing may offer 

some manufacturers relief from some 

testing costs. Component part testing 

may allow the cost of the third party 

testing to be spread over more units of 

the component part, which ultimately 

lowers the cost of third party testing per 

unit of the finished product. For 

example, if the hypothetical firms in the 

above examples were able to reduce the 

cost of third party testing by a factor of 

four using component part testing, in 

several (but not all) of the scenarios 

examined, the impact on those small 

firms could be reduced to the point that 

it would no longer be considered 

significant. However, component part 

testing is not likely to be an option for 

all manufacturers, for all component 

parts, or for all tests. Moreover, although 

it can reduce the cost of the third party 

testing, it may not reduce other costs 

associated with the final rule, such as 

the cost of samples, the cost of the 

recordkeeping, and other administrative 

costs. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69535 

It should be noted that the examples 

above were for illustration purposes 

only. The number of times a product 

may have to be tested for certification 

purposes or for periodic testing 

purposes may be more or less than four 

times. The cost of testing some toys and 

other children’s products could be 

higher or lower than the cost used in the 

above examples. The cost would be 

higher, for example, for products that 

had more component parts or for which 

the variability in the test results is 

greater, which could require more 

samples to be tested. The cost of testing 

could be lower for products that are 

subject to fewer safety rules or that 

contain fewer component parts. For 

some articles of apparel, for example, 

the only tests required might be for 

flammability and lead content on some 

component parts, for which component 

part testing might be possible. Although 

the examples suggest that some small 

businesses will be significantly 

adversely impacted by the final rule, 

some small businesses may have 

sufficient volume, sufficiently low 

testing costs, or sufficiently high 

revenue that the impact will not be 

significant. 

18. Possible Market Reactions and 

Caveats 

Manufacturers can be expected to 

react to a significant increase in their 

costs due to the final rule in several 

ways. Some manufacturers might 

attempt to redesign their products to 

reduce the number of tests required, by 

reducing the features or the number of 

component parts used in the products 

that require testing. Manufacturers and 

importers could also be expected to 

reduce the number of children’s 

products that they offer or, in some 

cases, exit the market for children’s 

products entirely. Some may go out of 

business altogether. 

The requirements of the final rule 

could be a barrier that inhibits new 

firms from entering the children’s 

product market, unless they expect to 

have relatively high-volume products. 

This could be an important factor for 

firms that expected to serve a niche 

market, such as firms with products 

intended for children with special 

needs. Although H.R. 2715 may provide 

significant relief to small batch 

manufacturers, the requirements could 

still be a barrier for some small batch 

manufacturers, home-based 

manufacturers, and craftspeople. The 

requirement for third party testing when 

there is a material change in a product’s 

design or manufacturing process could 

cause some small or low-volume 

manufacturers to forgo or delay 

implementing some improvements to a 

product’s design or manufacturing 

process in order to avoid the costs of 

third party testing. 

Although component part testing has 

the potential to reduce the costs of 

testing, component part testing might 

not be an option for all products or 

manufacturers. Component part testing 

most likely is an option for component 

parts that are common to multiple 

products (e.g., paints, bolts of a standard 

size). The potential for component part 

testing to reduce the cost of testing 

would be less for products that have 

component parts that are unique to the 

particular product. Component part 

testing is also not likely to offer 

significant cost savings for low-volume 

component parts or for component parts 

from which the component part 

manufacturer derives only a small 

percentage of revenue on regulated or 

children’s products. Moreover, to use 

component part testing, the 

manufacturer must be able to trace each 

component part for which component 

part testing was used, to the party who 

procured the test. Maintaining this 

traceability will involve some 

administrative and recordkeeping costs, 

which will reduce the potential benefit 

of component part testing. 

Manufacturers may be able to mitigate 

the adverse impacts if they are able to 

raise their prices to cover these costs. 

However, because few companies have 

perfectly inelastic demand curves, most 

firms will likely have to absorb some of 

the cost increases that result from the 

final rule. 

O. Conclusion 

The final rule will have a significant 

adverse impact on a substantial number 

of small businesses. The provisions of 

the rule that are expected to have the 

most significant impact are provisions 

related to requirements for the third 

party testing of children’s products and 

the associated administrative and 

recordkeeping requirements. The impact 

is expected to be disproportionate on 

small and low-volume manufacturers. 

This is because testing costs are 

relatively fixed. Therefore, the impact of 

testing costs, per unit, will be greater on 

low-volume producers than on highvolume producers. 

H.R. 2715 may provide significant 

relief from the third party testing costs 

to certain manufacturers who meet the 

definition of a ‘‘small batch 

manufacturer.’’ However, although the 

impact will be substantially reduced, 

some small batch manufacturers may 

still be significantly impacted by the 

requirements in the final rule. 

The other provisions of the rule 

related to protections against undue 

influence over a conformity assessment 

body and the voluntary consumer 

product labeling program are likely to 

have less significant impacts on small 

businesses. 

P. Federal Rules Which May Duplicate, 

Overlap, or Conflict With the Final Rule 

The final rule implements certain 

provisions of the CPSIA pertaining to 

the certification and continued testing 

of children’s products for compliance 

with children’s product safety rules. 

Certain children’s product safety rules 

contain some requirements for 

certification tests and reasonable test 

programs. However, any duplication, 

overlap, or conflict should be minimal. 

For example, the third party 

certification tests required by the final 

rule would satisfy the requirements for 

certification tests in any existing 

children’s product safety rule. Any 

production testing required by an 

existing children’s product safety rule 

can be used to increase the maximum 

period between periodic tests according 

to the provisions of the final rule. 

Q. Alternatives for Reducing the 

Adverse Impact on Small Businesses 

We recognize that the final rule will 

have a disproportionate impact on small 

and low-volume manufacturers. To a 

large degree, the impact is not avoidable 

because the CPSA, as amended by the 

CPSIA, requires that the certification of 

children’s products be based on test 

results from accredited third party 

conformity assessment bodies. However, 

we have incorporated into the final rule, 

some provisions that are intended to 

lessen the impact on small businesses. 

These include: Provisions allowing for 

longer maximum intervals between 

periodic testing if the manufacturer 

conducts certain other testing; allowing 

manufacturers to use component part 

testing; and permitting manufacturers 

and importers to rely upon the 

certifications issued by other parties as 

a basis for issuing their own finished 

product certificates, as provided by 16 

CFR part 1109. 

We also identified and considered 

several alternatives that could have 

reduced the impact on small businesses, 

but which for reasons discussed below, 

were not adopted in the final rule. 

These include: Providing additional 

testing relief for low-volume products; 

reducing the number of samples that 

must be tested by third party conformity 

assessment bodies; basing the frequency 

of third party testing on the risk of 

injury from the product; and allowing 


emcdonald on DSK5VPTVN1PROD with RULES3
69536 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

the use of XRF testing for lead content 

for more materials. 

R. Provisions Incorporated in the Final 

Rule 

1. Longer Maximum Periodic Testing 

Interval if the Manufacturer Conducts 

Other Testing 

The final rule provides for a longer 

maximum periodic testing interval if the 

manufacturer implements a production 

testing plan, as provided for in 

§ 1107.21(c) of the final rule. The 

manufacturer may consider the 

information obtained from the 

production testing in determining the 

appropriate interval and number of 

samples required for third party 

periodic testing, provided that third 

party periodic testing occurs at least 

once every two years. If the 

manufacturer conducts testing in an 

ISO/IEC 17025:2005-accredited testing 

laboratory in accordance with 

§ 1107.21(d) of the final rule, the 

maximum periodic testing interval is 

three years. However, this provision is 

expected to be of benefit primarily to 

larger manufacturers. 

2. Component Part Testing 

The final rule allows firms to conduct 

component part testing pursuant to the 

requirements in 16 CFR part 1109. This 

can reduce the cost to manufacturers 

where one component part might be 

common to more than one product. 

Such component parts might include 

paints, polymers used in molding 

different parts, and fasteners. In these 

cases, the component parts might be 

received in larger lots than the 

production lots of the products in which 

they are used. Therefore, the testing 

costs for those component parts will be 

spread over more units than if they were 

required to be tested on the final 

products only. 

3. Reliance on Certifications by Other 

Parties 

The final rule allows manufacturers 

and importers to rely upon testing 

obtained by or certifications made by 

another party as the basis for their own 

certificates, as allowed by 16 CFR part 

1109. These certifications can be for 

component parts or for finished 

products. This provision would be of 

value to importers, who may base their 

own certificate of conformity on the 

certificate for a finished product issued 

by a foreign manufacturer, provided that 

the requirements of 16 CFR part 1109 

are met. 

S. Alternatives That May Further 

Reduce the Impact on Small Businesses 

Additional Testing Relief for LowVolume Manufacturers of Children’s 

Products 

The proposed rule would include a 

provision that would provide some 

relief to low-volume manufacturers of 

children’s products, by exempting 

products from the periodic testing 

requirement until 10,000 units of the 

product have been manufactured or 

imported. Once 10,000 units have 

manufactured or imported, the periodic 

testing requirements would apply to the 

product. This provision did not relieve 

the manufacturer or importer from the 

obligation to have the product tested by 

a third party conformity assessment 

body for: (1) Certification purposes, and 

(2) when there had been a material 

change in the product’s design or 

manufacturing processes or sourcing of 

component parts. Thus, the 

manufacturer would have still been 

obligated to submit samples to a third 

party conformity assessment body to 

demonstrate that the product conforms 

with the applicable children’s product 

safety rules prior to introducing the 

product and when there has been a 

material change. The provision only 

relieved the manufacturer from the 

periodic testing requirements until 

10,000 units of the children’s product 

had been manufactured or imported. 

On August 12, 2011, H.R. 2715 was 

enacted into law. H.R. 2715 has the 

potential to provide substantial relief to 

‘‘small batch manufacturers,’’ which 

H.R 2751 defines as manufacturers that 

had no more than $1 million in total 

gross revenue from sales of all consumer 

products in the previous calendar year. 

H.R. 2751 also defines ‘‘covered 

product’’ as a consumer product 

manufactured by a small batch 

manufacturer where no more than 7,500 

units of the same product were 

manufactured in the previous calendar 

year. Because the provisions for small 

batch manufacturers in H.R. 2715 may 

provide relief to many of the same 

manufacturers at which the low-volume 

exemption in the proposed rule was 

aimed, we decided to defer action on 

the low-volume exemption. 

For most small batch manufacturers, 

the relief provided by H.R. 2715 may be 

greater than the relief that would have 

been provided by the low volumeexemption from the proposed rule 

because the H.R. 2715 provides small 

batch manufacturers with relief from 

both certification and periodic testing, 

with some exceptions, while the low 

volume exemption in the proposed rule 

only provided some relief from periodic 

testing. However, the partial exemption 

from periodic testing that the proposed 

rule would provide for products where 

fewer than 10,000 units had been 

imported or manufactured could 

provide some relief for some 

manufacturers of low-volume products 

that are not categorized as small batch 

manufacturers by H.R. 2715. There are 

likely some manufacturers that have 

low-volume products, but that also have 

gross sales that exceed $1 million. These 

manufacturers will receive no relief 

from the small batch manufacturer 

exceptions in H.R. 2715, but would have 

been provided some relief by the lowvolume exemption in the proposed rule. 

Consequently, including the partial 

exemption from periodic testing for lowvolume products from the proposed 

rule, could provide some relief to 

manufacturers of low-volume products 

that do not meet the definition of a 

small batch manufacturer. 

We have decided to reserve the 

provision of the proposed rule that 

would provide partial relief from 

periodic testing for low-volume 

products. The reason is that H.R. 2715 

directed us to seek public comment on 

opportunities to reduce the cost of third 

party testing requirements consistent 

with assuring compliance with any 

applicable consumer product safety 

rule, ban, standard, or regulation. It also 

contains special rules for small batch 

manufacturers and directs us to 

consider alternative testing 

requirements or to exempt small batch 

manufacturers from certain third party 

testing requirements. Thus, given these 

new statutory obligations resulting from 

H.R. 2715, we are reserving § 1107.21(e) 

so that we may consider how to address 

cost, low-volume products, and small 

batch issues more fully. 

1. Reduce the Number of Repeated 

Third Party Tests Required for 

Certification 

The final rule requires that 

manufacturers submit samples of 

children’s products to third party 

conformity assessment bodies to: (1) 

Certify that they comply with all 

applicable children’s product safety 

rules before they are distributed; (2) 

after material changes; and (3) 

periodically to ensure continued 

compliance with all applicable 

children’s product safety rules. The 

number of samples required is not 

specified, but would be based upon 

factors, such as the degree to which the 

manufacturing processes create 

products that are uniform in 

composition and quality, the testing 

interval, and the number of samples 

required to ensure with a high degree of 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69537 

9CPSC Memorandum to the Commission, from 

John W. Boja, Howard N. Tarnoff, Mary F. Toro, and 

Marc J. Schoem, ‘‘The Technological Feasibility of 

Reducing the Lead Content to 100 ppm: Compliance 

Data’’ (29 June 2011). 

assurance that a certified product 

continues to comply with all applicable 

children’s product safety rules. It is 

likely that most manufacturers will need 

to have a product third party tested 

multiple times for both certification and 

periodic testing purposes. 

An alternative that could provide 

some relief to small businesses is to 

require, for purposes of certifying a 

product, manufacturers to submit 

sufficient units of the product to 

conformity assessment bodies to ensure 

that the product can be tested for 

compliance with each applicable 

children’s safety rule, at least once, or 

as many times as required by the 

specific regulation, if different. The 

same requirement could apply to 

periodic testing: At least once during 

the periodic testing interval established 

by the rule (e.g., once a year) 

manufacturers would be required to 

submit sufficient units of the product to 

ensure that each applicable children’s 

product safety rule is evaluated at least 

once. In some cases, all of the required 

tests could be performed on one unit of 

the product. In other cases, more than 

one unit of the product might be 

required to test the product to all 

applicable children’s product safety 

rules. For example, more than one unit 

of a toy might be required to subject the 

toy to each use and abuse test that is 

applicable to the toy; the tests specified 

in the bicycle helmet standard require 

eight helmets. Nevertheless, each test 

would only need to be conducted one 

time. This could reduce the financial 

burden of the third party testing 

requirements on small businesses. 

Under this alternative, manufacturers 

could still be required to have a high 

degree of assurance that their children’s 

products complied with all applicable 

children’s product safety rules. 

However, the testing or inspections 

needed to provide the manufacturer 

with a high degree of assurance of 

compliance could be first or third party 

testing, or by other process control 

means, at the option of the 

manufacturer. The purpose of the 

required third party tests would be to 

provide objective evidence of 

compliance. 

We did not accept this alternative 

because, although it arguably would 

provide a greater level of evidence of 

compliance than what existed before the 

enactment of the CPSIA, it would not 

require enough third party testing to 

provide a high degree of assurance that 

children’s products complied with all 

applicable children’s product safety 

rules. An analysis of CPSC compliance 

data for children’s shoes found several 

examples where test results for one 

sample of an article indicated 

compliance with the lead content 

requirements, but tests results for a 

different sample of the same article 

showed lead levels that exceeded the 

standard.9 This suggests that testing one 

sample may not always be sufficient to 

detect noncomplying products. 

2. Allow Increased Use of XRF Analysis 

XRF analysis is a testing technique 

that can be used to measure the heavy 

metal content of materials. The cost of 

using XRF analysis testing is generally 

less expensive than using ICP analysis. 

Currently, we have approved XRF 

analysis for determining the lead 

content of homogenous polymer 

products and one type of XRF analysis 

(energy dispersive XRF using multiple 

monochromatic beams using the test 

method in ASTM F2853–10) for paints. 

We have not approved the use of XRF 

analysis for determining the lead 

content of metal component parts. 

However, allowing the use of XRF 

analysis for determining the lead 

content of metal component parts could 

substantially reduce the cost of the third 

party testing. The reduction could be 

especially significant for manufacturers 

of children’s products that have a lot of 

metal component parts. 

We decided not to allow the 

expanded use of XRF analysis to 

determine lead content at this time. 

However, we are continuing to evaluate 

the potential use of XRF analysis, and 

should we determine that XRF analysis 

can be sufficiently accurate in 

determining lead content, in a separate 

rulemaking, we could consider 

expanding the allowable use of XRF 

analysis for third party testing. 

Moreover, H.R. 2715 directed us to seek 

public comment on opportunities to 

reduce the cost of third party testing 

requirements consistent with assuring 

compliance with any applicable 

children’s product safety rule. Further, 

H.R. 2715 directs us to seek public 

comment on the extent to which 

technology, other than the technology 

already approved by the Commission, 

exists for third party conformity 

assessment bodies to test or to screen for 

testing consumer products subject to a 

third party testing requirement. 

Therefore, we may consider alternatives 

to reduce the cost of third party testing 

requirements more fully at a later date. 

3. Basing the Frequency of Periodic 

Testing on Risk of Injury or Illness 

The final rule requires that periodic 

testing be performed at least once every 

one to three years, depending on the 

other testing that a manufacturer opts to 

perform. An alternative that would 

reduce the burden of the rule on some 

small businesses is to lengthen the time 

period between required periodic tests 

for products, component parts, or rules 

for which the risk of serious injury or 

illness from a violation of a children’s 

product safety rule is low. This would 

reduce the burden on some 

manufacturers because it could reduce 

the amount of required third party 

testing. 

This alternative was not accepted 

because, given the number of children’s 

product safety rules and the large 

number and wide variety of children’s 

products to which they apply, its 

administration would be complex and 

would require a large investment of 

resources to analyze and rank the risk of 

serious injury or illness that could result 

from each product or product category 

failing to comply with each applicable 

children’s product safety rule and then 

determining the appropriate periodic 

testing requirements for the product or 

product category. 

4. Alternatives Not Considered Because 

They Would Conflict With the Statute 

We are aware of some alternatives that 

could reduce the burden of the rule but 

that were not considered in this 

rulemaking because adopting the 

alternative would conflict with the 

statute. For example, although we have 

been able to exempt some materials 

from the testing requirements that 

inherently do not contain lead in excess 

of the limits established by the CPSIA, 

we are not able to exempt materials 

from testing that can exceed those limits 

even if the health hazard associated 

with the materials or component parts is 

believed to be minimal. Likewise, we 

are not be able to exempt from the 

testing requirements products for which 

compliance with the applicable safety 

rule is thought to be very high even 

without a mandatory third party testing 

requirement. 

V. Paperwork Reduction Act 

The final rule contains information 

collection requirements that are subject 

to public comment and review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

preamble to the proposed rule contained 

a discussion of the estimated burden 

associated with the rule’s collection of 


emcdonald on DSK5VPTVN1PROD with RULES3
69538 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

information requirements (75 FR at 

28360 through 28361). 

Several commenters addressed issues 

relating to the Paperwork Reduction Act 

discussion. 

(Comment 113)—Some commenters 

noted that the preamble to the proposed 

rule states that we will likely request 

access to records only when we are 

investigating potentially defective or 

noncompliant products. The 

commenters concluded that having to 

integrate multiple systems to compile 

data should not be needed, as long as 

companies can provide the data upon 

request. One commenter noted that 

proposed § 1107.10 (b)(5)(i)(C) would 

require not only records of each 

certification test, but also ‘‘a description 

of how the product was certified as 

meeting the requirements, including 

how each applicable rule was evaluated, 

the test results and the actual values of 

the tests.’’ 

One commenter stated that it receives 

more than a thousand finished good test 

reports annually from CPSC-accepted 

third party labs. These reports often run 

50 to 125 pages in length and contain 

hundreds of data points and 

assessments. The commenter asserted 

that adding additional descriptive text 

to explain ‘‘how’’ the product was 

certified, simply adds no value. The 

commenter concluded that if the test 

report references an ASTM standard, 

and the results are acceptable, that 

should be sufficient without additional 

explanations. 

(Response 113)—The final rule 

reserves subpart B, which would 

contain proposed § 1107.10 and 

requirements for a reasonable test 

program for non-children’s products, 

including the recordkeeping 

requirements. Therefore, the final rule 

does not impose any recordkeeping 

requirements related to non-children’s 

products. 

With respect to children’s products, 

the recordkeeping requirements at 

§ 1107.26 of the final rule do not require 

descriptive text to explain ‘‘how’’ the 

children’s product was certified. The 

certification test methods are prescribed 

for children’s products. It should only 

be necessary for the manufacturer or 

importer to identify and store the new 

requirements that are not already part of 

their current recordkeeping systems and 

to be certain that the remaining 

documentation can be produced, upon 

request, in a manner that identifies 

clearly the requisite parts. 

(Comment 114)—Several commenters 

addressed our estimated resource 

requirements to manage the general 

recordkeeping requirements for testing 

and certification. One commenter stated 

that the toy industries’ experience in 

meeting the recordkeeping requirements 

of the interim enforcement policy is that 

the requirements are extremely 

burdensome, and the recordkeeping 

requirements contained in the proposed 

rule are much more extensive and will 

be even more costly. The commenter 

stated that our estimate of 200,000– 

300,000 hours to manage recordkeeping, 

equating to no more than 200 people 

across all industries impacted by the 

CPSIA, is much too low. Within the toy 

industry alone, the commenter 

estimated 10 times that many persons 

have been engaged along the global 

supply chain to manage the data and 

recordkeeping associated with the 

CPSIA’s existing requirements. 

Although we referenced a calculation of 

100,000 to 150,000 products to which 

the recordkeeping requirements would 

apply, the commenter stated that 

companies typically certify each SKU, 

and there is recordkeeping for every 

version, even if it is identical in all 

material respects. 

One commenter estimated that the 

true number of toys and games was 

closer to 2.5 million. The commenter’s 

estimate was based on a listing of 

808,465 toys and games on a popular 

commercial Web site (on August 3, 

2010), plus its estimate that the Web site 

only lists about one-third of the toys 

available. Given some specialty and 

other submarkets, the commenter 

thought that the final number of items 

in the Toys, Games, and Educational 

items category could be in excess of 4 

to 5 million individual products or 

stock-keeping units. The commenter 

also provided an estimate of 8 million 

apparel items available for children. 

However, the commenter did not 

provide the method or data sources it 

used for the latter estimates. Another 

commenter noted that its company had 

about 1,700 individual products 

annually, requiring testing, certification, 

and recordkeeping, or more than 1 

percent of the CPSC’s entire estimated 

number of products across all affected 

industries. 

(Response 114)—We acknowledge 

that our original estimate of the number 

of products that would be impacted was 

low, and we have increased 

significantly our estimate of the 

recordkeeping burden associated with 

the testing and certification 

requirements of the final rule. Based on 

the comments, and other research, we 

have revised our estimate of the number 

of children’s products. In the categories 

of toys, art and creative materials, 

furniture, and jewelry, we estimate that 

there are perhaps 241,000 different 

products. There are additional products 

in other categories, such as nursery or 

juvenile products, nontraditional toys 

(e.g., video games), CDs, bicycles, ATVs, 

party favors, and greeting cards 

intended for children, and some 

educational materials that could be 

affected by the final rule for which 

specific estimates have not been made. 

The estimates do not consider that some 

products might be produced at more 

than one location or certified by more 

than one importer. Therefore, we 

concluded that there could be 300,000 

non-apparel products that are covered 

by the rule. 

The original estimate did not account 

for the very large number of apparel 

products that would be covered by the 

final rule. The number of apparel 

products intended for children, 

including footwear, is estimated to be 

about 1.3 million. This would bring the 

total number of children’s products to 

about 1.6 million. 

The final rule has been changed to 

address some of the burdens mentioned 

by the commenters, such as not 

requiring records to be kept in the 

United States or translated into English, 

unless requested. 

Elsewhere in this issue of the Federal 

Register, we have published a notice 

seeking public comment on the issues in 

H.R. 2715, including other methods of 

lowering the cost of third party testing 

consistent with assuring compliance 

with the applicable consumer product 

safety rules, bans, standards, and 

regulations. 

(Comment 115)—One commenter 

asserted that its company’s testing 

program has been highly effective for 

more than 26 years, but it does not 

maintain the records that would be 

required by the proposed rules, and it 

would be very costly to do so. One 

commenter questioned whether the 

extensive recordkeeping on every item 

was necessary for the proper 

performance of the CPSC’s functions. 

Another commenter echoed the 

concern that the cost of the 

recordkeeping requirements would be 

high without providing any clear benefit 

to the agency’s mission or product 

safety. The commenter estimated that a 

major retailer would need to maintain 

records on 300,000 distinct products, 

which would cost the retailer $22 

million annually, using the estimated 

per product recordkeeping burden 

employed in the notice of proposed 

rulemaking. Another commenter stated 

that we should reduce the reporting 

burden by allowing manufacturers or 

importers to maintain their own 

recordkeeping systems if they meet the 

traceability requirements and ensure 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69539 

that products are certified properly 

before they enter into commerce. 

(Response 115)—With respect to 

recordkeeping requirements for 

reasonable testing programs for nonchildren’s products, we have reserved 

subpart B, which would contain 

requirements for reasonable testing 

programs for non-children’s products. 

Therefore, the final rule does not 

impose any recordkeeping requirements 

on manufacturers of non-children’s 

products. 

With respect to children’s products, 

we acknowledge that the recordkeeping 

requirements could require considerable 

resources to track the data and manage 

recordkeeping. As a result, the costs 

associated with the recordkeeping 

requirements could be a significant 

expense for some firms. However, as 

stated in the preamble to the proposed 

rule, the purpose of the documentation 

and recordkeeping requirements in the 

rule is to establish the identity of the 

product and to demonstrate that each 

product complies with the applicable 

rules when it is certified and on a 

continuing basis thereafter. 

Additionally, we note that retailers are 

not required to comply with the 

recordkeeping requirements of the rule, 

unless they are also the importer of the 

product. 

We also have revised the final rule to 

reduce the costs associated with the 

recordkeeping requirements. For 

example, the final rule does not require 

manufacturers to maintain the records at 

a location in the United States, as long 

as they can provide the records to us, 

after receiving a request to do so. Also, 

with the exception of the certificates of 

conformity, the records will not have to 

be maintained in the English language. 

Finally, the final rule does not require 

that the records be in a specific format. 

The final rule specifies the records or 

information that is required. However, 

manufacturers may maintain the records 

within their own recordkeeping systems 

if, as suggested by the commenter, they 

meet the traceability requirements and 

ensure that products are certified 

properly before they enter into 

commerce. 

(Comment 116)—Several comments 

provided estimates on the amount of 

time required for recordkeeping or 

information from which estimates could 

be derived. One commenter (a large toy 

manufacturer) stated that they had 

added six full-time employees to 

manage the data and recordkeeping 

associated with the CPSIA’s existing 

testing and certification requirements, 

and they further indicated that they had 

1,700 products tested annually for 

which recordkeeping would be 

required. The test reports are from 50 to 

125 pages in length and require 

maintaining for all products tested. The 

commenter estimated that their 

company accounted for greater than 1 

percent of all the hours that the CPSC 

had estimated for all children’s 

products. The commenter concluded 

that, based on this estimate, the actual 

number of hours required for 

recordkeeping by all companies would 

be higher than the CPSC’s estimate. 

Another commenter estimated that 

the recordkeeping will require about 

2.25 hours per test submitted; but due 

to varying lot sizes and requirements, 

they estimate that multiple tests per 

year could be required on a product. 

They estimate that the burden will be 3 

hours for one category of products that 

it manufactures and 5 hours for another, 

with an average across their product 

line of 3.5 hours. 

One commenter said that the time 

required for recordkeeping would be 

higher for manufacturers that specialize 

in high quality, but low volume 

products. The commenter estimated that 

it would take 6 to 10 employees to track 

the testing data and compile it into 

certificates of conformity, or about 6 to 

10 times the per-product labor required 

by the high volume, mass production 

manufacturers. The commenter 

estimated about 3 to 7.5 hours of 

recordkeeping would be required for 

high-quality, low-volume products. 

(Response 116)—Based on these 

comments, we have determined that for 

many children’s products, substantially 

more than 2 hours will be required for 

the associated recordkeeping. For 

products, such as toys, jewelry, 

children’s furniture and other children’s 

products, which are subject to third 

party testing to several different 

standards, we have determined that 5 

hours is a reasonable estimate. 

More hours will be required for some 

products to which many rules apply. 

Simpler products with few, or only one, 

applicable rule should require fewer 

hours for recordkeeping. For apparel 

and footwear products, we have 

determined that it is reasonable to use 

a lower estimate of the number of hours 

required for recordkeeping, such as 3 

hours. This estimate recognizes that 

there could be substantial recordkeeping 

required for some items, such as those 

that require testing for flammability and 

that contain various components (e.g., 

zippers, snaps, buttons, accessories) 

while other items, might require little 

testing. 

Title: Testing and Labeling Pertaining 

to Product Certification. 

Description: The final rule 

implements section 102(b) of the CPSIA, 

which requires certification of 

compliance for children’s products 

subject to a children’s product safety 

rule. A certification that a children’s 

product complies with the applicable 

children’s product safety rules must be 

supported by testing by an approved 

third party conformity assessment body. 

The final rule imposes recordkeeping 

requirements related to those testing 

and certification mandates. The 

recordkeeping requirements are 

intended to allow identification of each 

product and establish that each product 

is certified properly, before it enters 

commerce. In addition, the 

recordkeeping requirements require 

certification that a product has been 

retested properly for conformity with all 

applicable rules on a continuing basis, 

including after a material change in the 

product’s design or manufacturing 

processes, including the sourcing of 

component parts. 

Each manufacturer or importer of a 

children’s product subject to a 

children’s product safety rule would be 

required to establish and maintain the 

following records: 

• A copy of the Children’s Product 

Certificate (§ 1107.26(a)(1)); 

• Records of each certification test 

(§ 1107.26(a)(2)); 

• Records of the periodic tests 

(§ 1107.26(a)(3)); 

• Records of descriptions of all 

material changes in product design, 

manufacturing process, and sourcing of 

component parts, the certification tests 

run, and the test values (§ 1107.26(a)(5)); 

and 

• Records of undue influence 

procedures (§ 1107.26(a)(6)). 

Description of Respondents: The 

recordkeeping requirements apply to all 

manufacturers or importers of children’s 

products that are covered by one or 

more children’s product safety rules 

promulgated and/or enforced by the 

CPSC. We reviewed every industry 

category in the NAICS and selected 

those industry categories that included 

firms that could manufacture or sell 

such children’s products. Using data 

from the U.S. Census Bureau, we 

determined that there are more than 

37,000 manufacturers, almost 80,000 

wholesalers, and about 128,000 retailers 

in these categories. However, not all of 

the firms in these categories 

manufacture or import children’s 

products that are covered by children’s 

product safety rules. Therefore, these 

numbers would constitute a high 

estimate of the number of firms that are 

subject to the recordkeeping 

requirements. 

Estimate of the Burden: The hour 

burden of the recordkeeping 


emcdonald on DSK5VPTVN1PROD with RULES3
69540 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

10U.S. Department of Labor, Bureau of Labor 

Statistics, ‘‘Employer costs for Employee 

Compensation—March 2011, Table 9’’ (8 June 

2011). Available at: http://www.bls.gov/ 

news.release/ecec.t09.htm. Last accessed 8 July 

2011. 

requirements will likely vary greatly 

from product to product, depending 

upon such factors as the complexity of 

the product and the amount of testing 

that must be documented. We do not 

have comprehensive data on the 

universe of products that will be 

impacted. Therefore, estimates of the 

hour burden of the recordkeeping 

requirements are somewhat speculative. 

The preamble to the proposed rule (75 

FR at 28361) estimated that, on average, 

approximately 2 hours would be needed 

for recordkeeping per product; although 

we recognized that, for some products, 

particularly those subject to more than 

one standard or rule, would need a 

substantial amount of testing, and thus, 

the recordkeeping burden could be 

much higher than 2 hours. Conversely, 

products subject to one standard or that 

need little testing, could have a 

recordkeeping burden of less than 2 

hours. 

Based on the comments we received 

on the proposed rule, however, we have 

revised the estimated number of 

children’s products that are affected, as 

well as the hourly recordkeeping burden 

estimate. We now estimate that 

approximately 300,000 non-apparel 

children’s products will be covered by 

the rule and that an average of 5 hours 

will be needed for the recordkeeping 

associated with these products. We also 

estimate that there are approximately 

1.3 million children’s apparel and 

footwear products and that will require 

an average of 3 hours for the 

recordkeeping. Thus, the total hour 

burden of the recordkeeping associated 

with the final rule is 5.4 million hours 

(300,000 × 5 hours plus 1,300,000 × 3 

hours). 

Additionally, for the proposed rule, to 

calculate the cost of the recordkeeping 

burden, we used the total hourly 

compensation for private sector workers 

in management, professional, and 

related occupations, which is $48.91 per 

hour. This is based on the expectation 

that much of the recordkeeping will be 

done by chemists, engineers and quality 

control managers. Most commenters did 

not mention the occupational mix of the 

workers that would be involved in the 

recordkeeping associated with the rule. 

However, one commenter stated that the 

rule would result in an increase in his 

clerical and management staff. 

Therefore, to recognize that clerical, 

professional, and management staff will 

be involved in meeting the 

recordkeeping requirements of the rule, 

we will assume that personnel in 

‘‘management, professional, and related 

occupations’’ will be responsible for 

half of the recordkeeping, while 

personnel in ‘‘office and administrative 

support’’ occupations will be 

responsible for the other half. As of 

March 2011, these categories would 

average $36.43 per hour (http:// 

www.bls.gov/news.release/ 

ecec.t09.htm).10 At $36.43 per hour (i.e., 

the revised hourly compensation rate), 

the total cost of the recordkeeping 

associated with the testing and 

certification rule is approximately $197 

million (5.4 million hours × $36.43 = 

$196,722,000). 

Estimate Limitations: There are some 

limitations to the above estimates that 

warrant mentioning. 

While the estimates of the number of 

products are more accurate than the 

original estimates, they are not based on 

a well-designed survey or 

comprehensive database. Additionally, 

the extent to which some products 

might be certified by multiple 

importers, or are manufactured at 

different sites, has not been established. 

Recordkeeping for the flammability of 

children’s sleepwear might be captured 

in the OMB submission on another rule, 

but the recordkeeping associated with 

the lead content rules should be 

captured here. However, no adjustment 

for this has been made because we have 

not tried to separate children’s 

sleepwear from other apparel items. 

The recordkeeping considered here is 

best thought of as the recordkeeping 

mandated by the testing and 

certification requirements of section 102 

of the CPSIA. It would be impossible to 

separate the time associated with the 

initial certification, from the time 

related to periodic testing and 

documenting material changes, 

especially because it often involves 

issuing a new certificate. 

For finished goods manufacturers 

who also perform their own component 

testing, it is difficult to separate the 

recordkeeping burden associated with 

component part testing from the 

recordkeeping burden associated with 

the testing and labeling rule. This could 

lead to an overestimate of the costs 

associated with the testing and labeling 

rule and possibly result in 

underestimates associated with the 

component part testing rule. Better 

estimates may be possible if the 

recordkeeping burden is reevaluated 

after the rules are finalized. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have applied to the U.S. 

Office of Management and Budget 

(OMB) for a control number for this 

information collection, and we will 

publish a notice in the Federal Register 

providing the number when we receive 

approval from the OMB. 

VI. Environmental Considerations 

This final rule falls within the scope 

of the Commission’s environmental 

review regulations at 16 CFR 

1021.5(c)(2), which provides a 

categorical exclusion from any 

requirement for the agency to prepare an 

environmental assessment or 

environmental impact statement for 

product certification rules. 

VII. Executive Order 12988 

Executive Order 12988 (February 5, 

1996), requires agencies to state in clear 

language the preemptive effect, if any, of 

new regulations. The final rule is issued 

under authority of the CPSA and the 

CPSIA. The CPSA provision on 

preemption appears at section 26 of the 

CPSA. The CPSIA provision on 

preemption appears at section 231 of the 

CPSIA. The preemptive effect of this 

rule would be determined in an 

appropriate proceeding by a court of 

competent jurisdiction. 

VIII. Effective Date 

The preamble to the proposed rule 

indicated that a final rule would become 

effective 180 days after its date of 

publication in the Federal Register (75 

FR at 28361). However, on August 12, 

2011, the President signed H.R. 2715 

into law. H.R. 2715 revised the CPSIA 

in several different ways and also 

affected section 14(i)(2)(B)(ii) of the 

CPSA. H.R. 2715 also created a new 

section 14(i)(3)(B) of the CPSA, which 

requires us, no later than one year after 

H.R. 2715’s date of enactment, to review 

the public comments (on opportunities 

to reduce the costs of third party testing 

requirements) and directs us to 

‘‘prescribe new or revised third party 

testing regulations’’ if we determine that 

‘‘such regulations will reduce third 

party testing costs consistent with 

assuring compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations.’’ 

Consequently, we have finalized those 

provisions that H.R. 2715 did not affect 

directly. We also have decided to make 

the final rule effective on February 8, 

2013 so that parties can begin taking 

steps to develop internal processes, 

such as recordkeeping, and so that we 

and interested parties can consider how 

H.R. 2715 interacts with the final rule. 

List of Subjects in 16 CFR Part 1107 

Business and industry, Children, 

Consumer protection, Imports, 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69541 

Incorporation by reference, Product 

testing and certification, Records, 

Record retention, Toys. 

Accordingly, 16 CFR part 1107 is 

added to read as follows: 

PART 1107—TESTING AND LABELING 

PERTAINING TO PRODUCT 

CERTIFICATION 

Subpart A—General Provisions 

Sec. 

1107.1 Purpose. 

1107.2 Definitions. 

Subpart B—[Reserved] 

Subpart C—Certification of Children’s 

Products 

1107.20 General requirements. 

1107.21 Periodic testing. 

1107.23 Material change. 

1107.24 Undue influence. 

1107.26 Recordkeeping. 

Subpart D—Consumer Product Labeling 

Program 

1107.30 Labeling consumer products to 

indicate that the certification 

requirements of section 14 of the CPSA 

have been met. 

Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. 

L. 110–314, 122 Stat. 3016, 3017, 3022. 

Subpart A—General Provisions 

§ 1107.1 Purpose. 

This part establishes the protocols 

and standards for ensuring continued 

testing of children’s products 

periodically and when there has been a 

material change in the product’s design 

or manufacturing process and 

safeguarding against the exercise of 

undue influence by a manufacturer on 

a third party conformity assessment 

body. It also establishes a program for 

labeling of consumer products to 

indicate that the certification 

requirements have been met pursuant to 

sections 14(a)(2) and (i)(2)(B) of the 

Consumer Product Safety Act (CPSA) 

(15 U.S.C. 2063(a)(2) and (i)(2)(B)). 

§ 1107.2 Definitions. 

Unless otherwise stated, the 

definitions of the Consumer Product 

Safety Act and the Consumer Product 

Safety Improvement Act of 2008 apply 

to this part. The following definitions 

apply for purposes of this part: 

CPSA means the Consumer Product 

Safety Act. 

CPSC means the Consumer Product 

Safety Commission. 

Due care means the degree of care that 

a prudent and competent person 

engaged in the same line of business or 

endeavor would exercise under similar 

circumstances. Due care does not permit 

willful ignorance. 

High degree of assurance means an 

evidence-based demonstration of 

consistent performance of a product 

regarding compliance based on 

knowledge of a product and its 

manufacture. 

Identical in all material respects 

means there is no difference with 

respect to compliance to the applicable 

rules, bans, standards, or regulations 

between the samples to be tested for 

compliance and the finished product 

distributed in commerce. 

Manufacturer means the parties 

responsible for certification of a 

consumer product pursuant to 16 CFR 

part 1110. 

Manufacturing process means the 

techniques, fixtures, tools, materials, 

and personnel used to create the 

component parts and assemble a 

finished product. 

Material change means any change in 

the product’s design, manufacturing 

process, or sourcing of component parts 

that a manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable rules, bans, standards, or 

regulations. 

Third party conformity assessment 

body means a testing laboratory whose 

accreditation has been accepted by the 

CPSC to conduct certification testing on 

children’s products. Only third party 

conformity assessment bodies whose 

scope of accreditation includes the 

applicable required tests can be used for 

children’s product certification or 

periodic testing purposes. 

Subpart B—[Reserved] 

Subpart C—Certification of Children’s 

Products 

§ 1107.20 General requirements. 

(a) Manufacturers must submit a 

sufficient number of samples of a 

children’s product, or samples that are 

identical in all material respects to the 

children’s product, to a third party 

conformity assessment body for testing 

to support certification. The number of 

samples selected must be sufficient to 

provide a high degree of assurance that 

the tests conducted for certification 

purposes accurately demonstrate the 

ability of the children’s product to meet 

all applicable children’s product safety 

rules. 

(b) If the manufacturing process for a 

children’s product consistently creates 

finished products that are uniform in 

composition and quality, a 

manufacturer may submit fewer samples 

to provide a high degree of assurance 

that the finished product complies with 

the applicable children’s product safety 

rules. If the manufacturing process for a 

children’s product results in variability 

in the composition or quality of 

children’s products, a manufacturer may 

need to submit more samples to provide 

a high degree of assurance that the 

finished product complies with the 

applicable children’s product safety 

rules. 

(c) Except where otherwise specified 

by a children’s product safety rule, 

component part testing pursuant to 16 

CFR part 1109 may be used to support 

the certification testing requirements of 

this section. 

(d) If a product sample fails 

certification testing to the applicable 

children’s product safety rule(s), even if 

other samples have passed the same 

certification test, the manufacturer must 

investigate the reasons for the failure 

and take the necessary steps to address 

the reasons for the failure. A 

manufacturer cannot certify the 

children’s product until the 

manufacturer establishes, with a high 

degree of assurance that the finished 

product does comply with all applicable 

children’s product safety rules. 

§ 1107.21 Periodic testing. 

(a) General requirements for all 

manufacturers. All manufacturers of 

children’s products must conduct 

periodic testing. All periodic testing 

must be conducted by a third party 

conformity assessment body. Periodic 

testing must be conducted pursuant to 

either paragraph (b), (c), or (d) of this 

section or as provided in regulations 

under this title. The testing interval 

selected for periodic testing may be 

based on a fixed production interval, a 

set number of units produced, or 

another method chosen by the 

manufacturer based on the product 

produced and its manufacturing 

process, so long as the applicable 

maximum testing interval specified in 

paragraph (b), (c), or (d) of this section 

is not exceeded. Component part testing 

pursuant to 16 CFR part 1109 may be 

used to support the periodic testing 

requirements of this section. 

(b) A manufacturer must conduct 

periodic testing to ensure compliance 

with the applicable children’s product 

safety rules at least once a year, except 

as otherwise provided in paragraphs (c), 

and (d) of this section or as provided in 

regulations under this title. If a 

manufacturer does not conduct 

production testing under paragraph (c) 

of this section, or testing by a testing 

laboratory under paragraph (d) of this 

section, the manufacturer must conduct 

periodic testing as follows: 

(1) Periodic Testing Plan. 

Manufacturers must develop a periodic 


emcdonald on DSK5VPTVN1PROD with RULES3
69542 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

testing plan to ensure with a high degree 

of assurance that children’s products 

manufactured after the issuance of a 

Children’s Product Certificate, or since 

the previous periodic testing was 

conducted, continue to comply with all 

applicable children’s product safety 

rules. The periodic testing plan must 

include the tests to be conducted, the 

intervals at which the tests will be 

conducted, and the number of samples 

tested. At each manufacturing site, the 

manufacturer must have a periodic 

testing plan specific to each children’s 

product manufactured at that site. 

(2) Testing Interval. The testing 

interval selected must be short enough 

to ensure that, if the samples selected 

for testing pass the test, there is a high 

degree of assurance that the other 

untested children’s products 

manufactured during the testing interval 

comply with the applicable children’s 

product safety rules. The testing interval 

may vary depending upon the specific 

children’s product safety rules that 

apply to the children’s product, but may 

not exceed one year. Factors to be 

considered when determining the 

testing interval include, but are not 

limited to, the following: 

(i) High variability in test results, as 

indicated by a relatively large sample 

standard deviation in quantitative tests; 

(ii) Measurements that are close to the 

allowable numerical limit for 

quantitative tests; 

(iii) Known manufacturing process 

factors which could affect compliance 

with a rule. For example, if the 

manufacturer knows that a casting die 

wears down as the die nears the end of 

its useful life, the manufacturer may 

wish to test more often as the casting die 

wears down; 

(iv) Consumer complaints or warranty 

claims; 

(v) Introduction of a new set of 

component parts into the assembly 

process; 

(vi) The manufacture of a fixed 

number of products; 

(vii) Potential for serious injury or 

death resulting from a noncompliant 

children’s product; 

(viii) The number of children’s 

products produced annually, such that 

a manufacturer should consider testing 

a children’s product more frequently if 

the product is produced in very large 

numbers or distributed widely 

throughout the United States; 

(ix) The children’s product’s 

similarity to other children’s products 

with which the manufacturer is familiar 

and/or whether the children’s product 

has many different component parts 

compared to other children’s products 

of a similar type; or 

(x) Inability to determine the 

children’s product’s noncompliance 

easily through means such as visual 

inspection. 

(c)(1) If a manufacturer implements a 

production testing plan as described in 

paragraph (c)(2) of this section to ensure 

continued compliance of the children’s 

product with a high degree of assurance 

to the applicable children’s product 

safety rules, the manufacturer must 

submit samples of its children’s product 

to a third party conformity assessment 

body for periodic testing to the 

applicable children’s product safety 

rules at least once every two years. A 

manufacturer may consider the 

information obtained from production 

testing when determining the 

appropriate testing interval and the 

number of samples needed for periodic 

testing to ensure that there is a high 

degree of assurance that the other 

untested children’s products 

manufactured during the testing interval 

comply with the applicable children’s 

product safety rules. 

(2) Production Testing Plan. A 

production testing plan describes the 

production management techniques and 

tests that must be performed to provide 

a high degree of assurance that the 

products manufactured after 

certification continue to meet all the 

applicable children’s product safety 

rules. A production testing plan may 

include recurring testing or the use of 

process management techniques, such 

as control charts, statistical process 

control programs, or failure modes and 

effects analyses (FMEAs) designed to 

control potential variations in product 

manufacturing that could affect the 

product’s ability to comply with the 

applicable children’s product safety 

rules. A manufacturer may use 

measurement techniques that are 

nondestructive and tailored to the needs 

of an individual product to ensure that 

a product complies with all applicable 

children’s product safety rules. Any 

production test method used to conduct 

production testing must be effective in 

determining compliance. Production 

testing cannot consist solely of 

mathematical methods (such as an 

FMEA, with no additional components, 

or computer simulations). Production 

testing must include some testing, 

although it is not required that the test 

methods employed be the test methods 

used for certification. A manufacturer 

must document the production testing 

methods used to ensure continuing 

compliance and the basis for 

determining that the production testing 

plan provides a high degree of assurance 

that the product being manufactured 

continues to comply with all applicable 

children’s product safety rules. A 

production testing plan must contain 

the following elements: 

(i) A description of the production 

testing plan, including, but not limited 

to, a description of the process 

management techniques used, the tests 

to be conducted, or the measurements to 

be taken; the intervals at which the tests 

or measurements will be made; the 

number of samples tested; and the basis 

for determining that the combination of 

process management techniques and 

tests provide a high degree of assurance 

of compliance if they are not the tests 

prescribed for the applicable children’s 

product safety rule; 

(ii) At each manufacturing site, the 

manufacturer must have a production 

testing plan specific to each children’s 

product manufactured at that site; 

(iii) The production testing interval 

selected for tests must ensure that, if the 

samples selected for production testing 

comply with an applicable children’s 

product safety rule, there is a high 

degree of assurance that the untested 

products manufactured during that 

testing interval also will comply with 

the applicable children’s product safety 

rule. Production testing intervals should 

be appropriate for the specific testing or 

alternative measurements being 

conducted. 

(3) If a production testing plan as 

described in this paragraph (c) fails to 

provide a high degree of assurance of 

compliance with all applicable 

children’s product safety rules, the 

CPSC may require the manufacturer to 

meet the requirements of paragraph (b) 

of this section or modify its production 

testing plan to ensure a high degree of 

assurance of compliance. 

(d)(1) For manufacturers conducting 

testing to ensure continued compliance 

with the applicable children’s product 

safety rules using a testing laboratory 

accredited to ISO/IEC 17025:2005(E), 

‘‘General requirements for the 

competence of testing and calibration 

laboratories,’’ periodic tests by a third 

party conformity assessment body must 

be conducted at least once every three 

years. Any ISO/IEC 17025:2005(E)- 

accredited testing laboratory used for 

ensuring continued compliance must be 

accredited by an accreditation body that 

is accredited to ISO/IEC 17011:2004(E), 

‘‘Conformity assessment—General 

requirements for accreditation bodies 

accrediting conformity assessment 

bodies.’’ The test method(s) used by an 

ISO/IEC 17025:2005(E)-accredited 

testing laboratory when conducting 

testing to ensure continued compliance 

must be the same test method(s) used 

for certification to the applicable 

children’s product safety rules. 


emcdonald on DSK5VPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 69543 

Manufacturers must conduct testing 

using the ISO/IEC 17025:2005(E)- 

accredited testing laboratory frequently 

enough to provide a high degree of 

assurance that the children’s product 

continues to comply with the applicable 

children’s product safety rules. A 

manufacturer may consider the 

information obtained from testing 

conducted by an ISO/IEC 

17025:2005(E)-accredited testing 

laboratory when determining the 

appropriate testing interval and the 

number of samples for periodic testing 

that are needed to ensure that there is 

a high degree of assurance that the other 

untested children’s products 

manufactured during the testing interval 

comply with the applicable children’s 

product safety rules. 

(2) If the continued testing described 

in paragraph (d)(1) of this section fails 

to provide a high degree of assurance of 

compliance with all applicable 

children’s product safety rules, the 

CPSC may require the manufacturer to 

meet the requirements of paragraph (b) 

of this section or modify the testing 

frequency or number of samples 

required to ensure a high degree of 

assurance of continued compliance. 

(e) [Reserved] 

(f) [Reserved] 

(g) The Director of the Federal 

Register approves the incorporations by 

reference of the standards in this section 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may inspect a copy 

of the standards at the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone (301) 504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(1) International Organization for 

Standardization (ISO), 1, ch. de la VoieCreuse, Case postale 56, CH–1211 

Geneva 20, Switzerland; Telephone +41 

22 749 01 11, Fax +41 22 733 34 30; 

http://www.iso.org/iso/home.html. 

(i) ISO/IEC 17011:2004(E), 

‘‘Conformity assessment—General 

requirements for accreditation bodies 

accrediting conformity assessment 

bodies,’’ First Edition, September 1, 

2004 (Corrected version February 15, 

2005); 

(ii) ISO/IEC 17025:2005(E), ‘‘General 

requirements for the competence of 

testing and calibration laboratories,’’ 

Second Edition, May 15, 2005. 

(2) [Reserved] 

§ 1107.23 Material change. 

(a) General Requirements. If a 

children’s product undergoes a material 

change in product design or 

manufacturing process, including the 

sourcing of component parts, which a 

manufacturer exercising due care 

knows, or should know, could affect the 

product’s ability to comply with the 

applicable children’s product safety 

rules, the manufacturer must submit a 

sufficient number of samples of the 

materially changed children’s product 

for testing by a third party conformity 

assessment body and issue a new 

Children’s Product Certificate. The 

number of samples submitted must be 

sufficient to provide a high degree of 

assurance that the materially changed 

component part or finished product 

complies with the applicable children’s 

product safety rules. A manufacturer of 

a children’s product that undergoes a 

material change cannot issue a new 

Children’s Product Certificate for the 

product until the product meets the 

requirements of the applicable 

children’s product safety rules. The 

extent of such testing may depend on 

the nature of the material change. When 

a material change is limited to a 

component part of the finished 

children’s product and does not affect 

the ability of other component parts of 

the children’s product or the finished 

children’s product to comply with other 

applicable children’s product safety 

rules, a manufacturer may issue a new 

Children’s Product Certificate based on 

the earlier third party certification tests 

and on test results of the changed 

component part conducted by a third 

party conformity assessment body. A 

manufacturer must exercise due care to 

ensure that any component part 

undergoing component part-level testing 

is identical in all material respects to 

the component part on the finished 

children’s product. Changes that cause a 

children’s product safety rule to no 

longer apply to a children’s product are 

not considered to be material changes. 

(b) Product Design. For purposes of 

this subpart, the term ‘‘product design’’ 

includes all component parts, their 

composition, and their interaction and 

functionality when assembled. To 

determine which children’s product 

safety rules apply to a children’s 

product, a manufacturer should 

examine the product design for the 

children’s product as received or 

assembled by the consumer. 

(c) Manufacturing Process. A material 

change in the manufacturing process is 

a change in how the children’s product 

is made that could affect the finished 

children’s product’s ability to comply 

with the applicable children’s product 

safety rules. For each change in the 

manufacturing process, a manufacturer 

should exercise due care to determine if 

compliance to an existing applicable 

children’s product safety rule could be 

affected, or if the change results in a 

newly applicable children’s product 

safety rule. 

(d) Sourcing of Component Parts. A 

material change in the sourcing of 

component parts results when the 

replacement of one component part of a 

children’s product with another 

component part could affect compliance 

with the applicable children’s product 

safety rule. This includes, but is not 

limited to, changes in component part 

composition, component part supplier, 

or the use of a different component part 

from the same supplier who provided 

the initial component part. 

§ 1107.24 Undue influence. 

(a) Each manufacturer must establish 

procedures to safeguard against the 

exercise of undue influence by a 

manufacturer on a third party 

conformity assessment body. 

(b) The procedures required in 

paragraph (a) of this section, at a 

minimum, must include: 

(1) Safeguards to prevent attempts by 

the manufacturer to exercise undue 

influence on a third party conformity 

assessment body, including a written 

policy statement from company officials 

that the exercise of undue influence is 

not acceptable, and directing that every 

appropriate staff member receive 

training on avoiding undue influence, 

and sign a statement attesting to 

participation in such training; 

(2) A requirement that upon 

substantive changes to the requirements 

in this section regarding avoiding undue 

influence, the appropriate staff must be 

retrained regarding those changed 

requirements. 

(3) A requirement to notify the CPSC 

immediately of any attempt by the 

manufacturer to hide or exert undue 

influence over test results; and 

(4) A requirement to inform 

employees that allegations of undue 

influence may be reported 

confidentially to the CPSC and a 

description of the manner in which 

such a report can be made. 

§ 1107.26 Recordkeeping. 

(a) A manufacturer of a children’s 

product subject to an applicable 

children’s product safety rule must 

maintain the following records: 

(1) A copy of the Children’s Product 

Certificate for each product. The 

children’s product covered by the 

certificate must be clearly identifiable 


emcdonald on DSK5VPTVN1PROD with RULES3
69544 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Rules and Regulations 

and distinguishable from other 

products; 

(2) Records of each third party 

certification test. The manufacturer 

must have separate certification tests 

records for each manufacturing site; 

(3) Records of one of the following for 

periodic tests of a children’s product: 

(i) A periodic test plan and periodic 

test results; 

(ii) A production testing plan, 

production test results, and periodic test 

results; or 

(iii) Testing results of tests conducted 

by a testing laboratory accredited to 

ISO/IEC 17025:2005(E) and periodic test 

results. 

(4) [Reserved]; 

(5) Records of descriptions of all 

material changes in product design, 

manufacturing process, and sourcing of 

component parts, and the certification 

tests run and the test values; and 

(6) Records of the undue influence 

procedures, including training materials 

and training records of all employees 

trained on these procedures, including 

attestations described at § 1107.24(b)(1). 

(b) A manufacturer must maintain the 

records specified in paragraph (a) of this 

section for five years. The manufacturer 

must make these records available, 

either in hard copy or electronically, 

such as through an Internet Web site, for 

inspection by the CPSC upon request. 

Records may be maintained in 

languages other than English if they can 

be: 

(1) Provided immediately by the 

manufacturer to the CPSC; and 

(2) Translated accurately into English 

by the manufacturer within 48 hours of 

a request by the CPSC, or any longer 

period negotiated with CPSC staff. 

Subpart D—Consumer Product 

Labeling Program 

§ 1107.30 Labeling consumer products to 

indicate that the certification requirements 

of section 14 of the CPSA have been met. 

(a) Manufacturers and private labelers 

of a consumer product may indicate, by 

a uniform label on, or provided with the 

product, that the product complies with 

any consumer product safety rule under 

the CPSA, or with any similar rule, ban, 

standard or regulation under any other 

act enforced by the CPSC. 

(b) The label must be visible and 

legible, and consist of the following 

statement: 

Meets CPSC Safety Requirements 

(c) A consumer product may bear the 

label if the manufacturer or private 

labeler has certified, pursuant to section 

14 of the CPSA, that the consumer 

product complies with all applicable 

consumer product safety rules under the 

CPSA and with all rules, bans, 

standards, or regulations applicable to 

the product under any other act 

enforced by the Consumer Product 

Safety Commission. 

(d) A manufacturer or private labeler 

may use a label in addition to the label 

described in paragraph (b) on the 

consumer product, as long as such label 

does not alter or mislead consumers as 

to the meaning of the label described in 

paragraph (b) of this section. A 

manufacturer or private labeler must not 

imply that the CPSC has tested, 

approved, or endorsed the product. 

Dated: October 21, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–27678 Filed 11–7–11; 8:45 am] 

BILLING CODE 6355–01–P 


emcdonald on DSK5VPTVN1PROD with RULES3